Racial and ethnic representation across acral lentiginous melanoma clinical trials

Racial and ethnic representation across acral lentiginous melanoma clinical trials | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Short Report Racial and ethnic representation across acral lentiginous melanoma clinical trials Faith Simmonds, Diddier Prada, Rolando Perez-Lorenzo This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8097218/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Acral lentiginous melanoma (ALM) is a rare form of cutaneous melanoma (CM) affecting the palm, soles and nailbeds. ALM predominantly affects people with skin of color, and it is the most common form of CM diagnosed in Black populations. Globally, ALM is the predominant CM subtype diagnosed in certain Asian and Latin American countries. Thus, it is imperative that ALM clinical trials reflect the diversity of participants affected. The purpose of this study is to assess racial and ethnic representation in Phase I-IV clinical trials for ALM using The U.S. National Library of Medicine clinical trials database and PubMed. 11 clinical trials with 394 participants were included in our analysis. Nine clinical trials included other melanoma subtypes, as, 39.6% of participants were diagnosed with ALM, 39.3% with mucosal melanoma, and 16.5% with other subtypes or skin conditions. Six clinical trials reported race and ethnicity, and we found that 79.4% of the participants were White, 15.9% were Asian, 3.2% were Black, and 0.5% were reported as more than one race. Only three studies reported ethnicity, in which only 11.30% of participants were Hispanic. Compared to the U.S. Census Bureau and a previously published Surveillance, Epidemiology, and End Results study, White participants were overall highly represented, and racial and ethnic minority participants were underrepresented. Our findings highlight the need for the systematic inclusion of racial and ethnic minority groups and improved demographic reporting in ALM clinical trials. Acral lentiginous melanoma clinical trials diversity race and ethnicity Introduction Acral lentiginous melanoma (ALM) is a rare and aggressive subtype of cutaneous melanoma (CM) that occurs on the palms, soles, and nails, accounting for only 2–3% of melanoma cases [ 4 ]. Unlike other subtypes of CM, which predominantly affect non-Hispanic White populations, ALM mainly affects people with skin of color. In the United States, ALM is the most common form of CM diagnosed in Black individuals [ 3 ]. Globally, ALM is the most frequently diagnosed form of melanoma in Asian countries, such as Singapore, Japan, China, and Taiwan [ 2 ]. In Latin America, the prevalence of ALM varies depending on the ancestral composition of specific countries. However, ALM comprises most melanoma diagnoses in countries such as Mexico and Peru [ 2 ]. Most clinical trials used to inform treatment guidelines are either based on other CM subtypes or include ALM only as a subset, rather than being specifically for ALM [ 5 ]. Furthermore, given the racial and ethnic diversity of individuals diagnosed with ALM, clinical trial participants must reflect this diversity. Increasing the inclusion of ALM and historically underrepresented groups will significantly improve the generalizability of results, ensuring that the benefits and risk profiles of therapies are reflective of all melanoma subtypes and diverse populations. Here, we aimed to evaluate the racial and ethnic representation in global clinical trials for ALM. Methods We identified Phase I-IV clinical trials published after 2000 using The U.S. National Library of Medicine clinical trials database (clinicaltrials.gov) and PubMed on September 24, 2025. We used the search term “Acral Lentiginous Melanoma” in both databases and excluded studies that are actively recruiting participants, did not have a completed status, corresponding publication, or available results. Additionally, we only included trials that specified the number of participants with ALM. On PubMed, we filtered articles to include those classified as “Clinical Trial”. When reporting racial and ethnic diversity across studies, the denominator was based on studies that reported race and ethnicity. Racial and ethnic data were reported using definitions from the U.S. Census Bureau. To compare participant demographics for studies conducted in the United States to racial and ethnic diversity in the country, we compared racial and ethnic representation to the U.S. Census Bureau population estimates from July 1, 2024 [ 7 ]. We also identified differences in clinical trial diversity from ALM demographics as reported by a previously published Surveillance, Epidemiology, and End Results (SEER) study, which included ALM cases diagnosed from 2006–2015 and reported in 18 population-based registries [ 6 ]. Results 11 clinical trials resulting in a total of 394 participants were included in our analysis. Six trials were conducted in the United States; two were conducted in China, and one in Japan. Nine of our included trials included other melanoma subtypes. 39.6% of participants (n = 156) were diagnosed with acral lentiginous melanoma, 39.3% with mucosal melanoma (n = 155), and 16.5% were diagnosed with other subtypes or skin conditions, including chronic-sun damage (n = 24), ocular melanoma (n = 4), melanoma of the soft part (n = 1), or other subtypes of cutaneous melanoma (n = 36). Six of these clinical trials with a total of 189 participants reported race and ethnicity (Table 1 ). In these studies that reported race, 79.4% of the participants were White (n = 150), 3.2% were Black (n = 6), 15.9% were Asian (n = 30), and 0.5% were reported as more than one race (n = 1). Only three studies reported ethnicity (n = 71), in which only 11.30% of participants were Hispanic (n = 8). Table 1 Title: Racial and ethnic representation in clinical trials reporting race and ethnicity demographics Race and Ethnicity Percentage of participants across clinical trials (n = 189) White 79.4% (150) Black 3.2% (6) Asian 15.9% (30) Two or more races 0.5% (1) Hispanic or Latino* 11.3% (8) 144 participants were included in melanoma clinical trials within the United States and reported race and ethnicity. The proportion of Black, Asian, Hispanic, and more than one race participants was lower than the racial and ethnic distribution in the U.S. as reported by the U.S. Census Bureau. (Table 2 ). Conversely, there was a larger proportion of White participants in clinical trials compared to the proportion of White individuals in the U.S. Census. Similarly, there were a smaller proportion of Black, Asian and Hispanic participants in clinical trials compared to the SEER study (Table 2 ). Table 2 Title: Comparison of racial and ethnic representation in U.S, clinical trials compared to US Census and SEER populations for ALM Race and Ethnicity Participants across US clinical trials (n = 144) US Census Bureau Population Estimates SEER Study Participants (n = 1082) White 88.9% (128) 75.3% 69.8% (755) Black 4.2% (6) 13.7% 7% (76) Asian 2.8% (28) 6.4% 8% (87) Two or more races 0.6% (1) 3.1% - Hispanic or Latino* 11.3% (8) 19.5% 15.2% (164) Discussion In this review of clinical trials for ALM, we found that among the five studies reporting race and ethnicity, participants with skin of color were underrepresented relative to both the U.S. Census Bureau and the previously published ALM SEER study [ 6 , 7 ]. Notably, ethnicity was reported in only three studies, highlighting the need to improve both race and ethnicity reporting in published clinical trials. An important limitation of this study is that none of the included clinical trials differentiated racial and ethnic composition of participants specifically with ALM, which prevents us from determining the exact demographic of this subgroup. However, ALM represented the second largest proportion of participants, following mucosal melanoma, which is also more prevalent in minority populations [ 3 ]. Thus, the findings from this study are still informative regarding the racial and ethnic representation in histologic subtypes that disproportionately affect minority groups. Additionally, the small sample size and the broad classifications used for race and ethnicity did not have the granularity required to provide insights into subgroup compositions. Given the ancestral differences and resulting genetic variation across racial and ethnic groups, more precise demographic classifications may heighten understanding of differences in trial outcomes across diverse populations. This highlights the urgent need for the systematic inclusion of racial and ethnic minority populations in ALM clinical trials, as well as more detailed demographic reporting for individual tumor types in studies encompassing multiple melanoma subtypes. Increasing the racial and ethnic diversity, as well as global inclusivity of clinical trials for ALM, is especially pertinent given the differences in prevalence and participant demographics worldwide. Improving public awareness of clinical trials, conducting trials in racially and ethnically diverse areas, and addressing the financial and language barriers that limit participation, may increase diverse representation in future studies. Furthermore, improving global inclusivity, specifically in low- or middle-income countries, will also require increased funding and modulations to current regulatory processes that affect clinical trial approval [ 1 ]. Identifying and implementing global and inclusive solutions to these barriers will be essential for improving diversity in future clinical trials for ALM. Statement of Declarations Author Contribution FS and RPL conceptualized the project. FS, DP, and RPL all contributed to manuscript writing and reviewing. Acknowledgement Not applicable. The authors declare that they have no conflict of interest. References Adewole T, Albrecht B, Beg S, Brawley O, Chang IF, Daly B et al (2024) Advancing Global Health Equity in Oncology Clinical Trial Access. Cancer Discov 14(12):2317–2323 Basurto-Lozada P, Molina‐Aguilar C, Castaneda‐Garcia C, Vázquez‐Cruz ME, Garcia‐Salinas OI, Álvarez‐Cano A et al (2021) Acral lentiginous melanoma: Basic facts, biological characteristics and research perspectives of an understudied disease. Pigment Cell Melanoma Res 34(1):59–71 Brunsgaard EK, Wu YP, Grossman D (2023) Melanoma in skin of color: Part I. Epidemiology and clinical presentation. J Am Acad Dermatol 89(3):445–456 Carvalho LAD, Aguiar FC, Smalley KSM, Possik PA (2023) Acral melanoma: new insights into the immune and genomic landscape. Neoplasia 46:100947 Dugan MM, Perez MC, Karapetyan L, Zager JS (2024) Management of acral lentiginous melanoma: current updates and future directions. Front Oncol. ;14 Huang K, Fan J, Misra S (2020) Acral Lentiginous Melanoma: Incidence and Survival in the United States, 2006–2015, an Analysis of the SEER Registry. J Surg Res 251:329–339 U.S. Census Bureau QuickFacts: United States [Internet]. Washington, D.C: U.S. Census Bureau; Available from: https://www.census.gov/quickfacts/fact/table/US Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 24 Nov, 2025 Reviewers invited by journal 23 Nov, 2025 Editor assigned by journal 14 Nov, 2025 Submission checks completed at journal 14 Nov, 2025 First submitted to journal 12 Nov, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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Unlike other subtypes of CM, which predominantly affect non-Hispanic White populations, ALM mainly affects people with skin of color. In the United States, ALM is the most common form of CM diagnosed in Black individuals [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Globally, ALM is the most frequently diagnosed form of melanoma in Asian countries, such as Singapore, Japan, China, and Taiwan [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In Latin America, the prevalence of ALM varies depending on the ancestral composition of specific countries. However, ALM comprises most melanoma diagnoses in countries such as Mexico and Peru [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eMost clinical trials used to inform treatment guidelines are either based on other CM subtypes or include ALM only as a subset, rather than being specifically for ALM [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Furthermore, given the racial and ethnic diversity of individuals diagnosed with ALM, clinical trial participants must reflect this diversity. Increasing the inclusion of ALM and historically underrepresented groups will significantly improve the generalizability of results, ensuring that the benefits and risk profiles of therapies are reflective of all melanoma subtypes and diverse populations. Here, we aimed to evaluate the racial and ethnic representation in global clinical trials for ALM.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eWe identified Phase I-IV clinical trials published after 2000 using The U.S. National Library of Medicine clinical trials database (clinicaltrials.gov) and PubMed on September 24, 2025. We used the search term \u0026ldquo;Acral Lentiginous Melanoma\u0026rdquo; in both databases and excluded studies that are actively recruiting participants, did not have a completed status, corresponding publication, or available results. Additionally, we only included trials that specified the number of participants with ALM. On PubMed, we filtered articles to include those classified as \u0026ldquo;Clinical Trial\u0026rdquo;.\u003c/p\u003e\u003cp\u003eWhen reporting racial and ethnic diversity across studies, the denominator was based on studies that reported race and ethnicity. Racial and ethnic data were reported using definitions from the U.S. Census Bureau. To compare participant demographics for studies conducted in the United States to racial and ethnic diversity in the country, we compared racial and ethnic representation to the U.S. Census Bureau population estimates from July 1, 2024 [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. We also identified differences in clinical trial diversity from ALM demographics as reported by a previously published Surveillance, Epidemiology, and End Results (SEER) study, which included ALM cases diagnosed from 2006\u0026ndash;2015 and reported in 18 population-based registries [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e11 clinical trials resulting in a total of 394 participants were included in our analysis. Six trials were conducted in the United States; two were conducted in China, and one in Japan. Nine of our included trials included other melanoma subtypes. 39.6% of participants (n\u0026thinsp;=\u0026thinsp;156) were diagnosed with acral lentiginous melanoma, 39.3% with mucosal melanoma (n\u0026thinsp;=\u0026thinsp;155), and 16.5% were diagnosed with other subtypes or skin conditions, including chronic-sun damage (n\u0026thinsp;=\u0026thinsp;24), ocular melanoma (n\u0026thinsp;=\u0026thinsp;4), melanoma of the soft part (n\u0026thinsp;=\u0026thinsp;1), or other subtypes of cutaneous melanoma (n\u0026thinsp;=\u0026thinsp;36).\u003c/p\u003e\u003cp\u003eSix of these clinical trials with a total of 189 participants reported race and ethnicity (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). In these studies that reported race, 79.4% of the participants were White (n\u0026thinsp;=\u0026thinsp;150), 3.2% were Black (n\u0026thinsp;=\u0026thinsp;6), 15.9% were Asian (n\u0026thinsp;=\u0026thinsp;30), and 0.5% were reported as more than one race (n\u0026thinsp;=\u0026thinsp;1). Only three studies reported ethnicity (n\u0026thinsp;=\u0026thinsp;71), in which only 11.30% of participants were Hispanic (n\u0026thinsp;=\u0026thinsp;8).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eTitle: Racial and ethnic representation in clinical trials reporting race and ethnicity demographics\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRace and Ethnicity\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePercentage of participants across clinical trials (n\u0026thinsp;=\u0026thinsp;189)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWhite\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e79.4% (150)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBlack\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e3.2% (6)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAsian\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e15.9% (30)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTwo or more races\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.5% (1)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHispanic or Latino*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e11.3% (8)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e144 participants were included in melanoma clinical trials within the United States and reported race and ethnicity. The proportion of Black, Asian, Hispanic, and more than one race participants was lower than the racial and ethnic distribution in the U.S. as reported by the U.S. Census Bureau. (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Conversely, there was a larger proportion of White participants in clinical trials compared to the proportion of White individuals in the U.S. Census. Similarly, there were a smaller proportion of Black, Asian and Hispanic participants in clinical trials compared to the SEER study (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eTitle: Comparison of racial and ethnic representation in U.S, clinical trials compared to US Census and SEER populations for ALM\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRace and Ethnicity\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eParticipants across US clinical trials (n\u0026thinsp;=\u0026thinsp;144)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eUS Census Bureau Population Estimates\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSEER Study Participants (n\u0026thinsp;=\u0026thinsp;1082)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWhite\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e88.9% (128)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e75.3%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e69.8% (755)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBlack\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e4.2% (6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e13.7%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e7% (76)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAsian\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e2.8% (28)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e6.4%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e8% (87)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTwo or more races\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.6% (1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e3.1%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHispanic or Latino*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e11.3% (8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e19.5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e15.2% (164)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this review of clinical trials for ALM, we found that among the five studies reporting race and ethnicity, participants with skin of color were underrepresented relative to both the U.S. Census Bureau and the previously published ALM SEER study [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Notably, ethnicity was reported in only three studies, highlighting the need to improve both race and ethnicity reporting in published clinical trials.\u003c/p\u003e\u003cp\u003eAn important limitation of this study is that none of the included clinical trials differentiated racial and ethnic composition of participants specifically with ALM, which prevents us from determining the exact demographic of this subgroup. However, ALM represented the second largest proportion of participants, following mucosal melanoma, which is also more prevalent in minority populations [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Thus, the findings from this study are still informative regarding the racial and ethnic representation in histologic subtypes that disproportionately affect minority groups.\u003c/p\u003e\u003cp\u003eAdditionally, the small sample size and the broad classifications used for race and ethnicity did not have the granularity required to provide insights into subgroup compositions. Given the ancestral differences and resulting genetic variation across racial and ethnic groups, more precise demographic classifications may heighten understanding of differences in trial outcomes across diverse populations. This highlights the urgent need for the systematic inclusion of racial and ethnic minority populations in ALM clinical trials, as well as more detailed demographic reporting for individual tumor types in studies encompassing multiple melanoma subtypes.\u003c/p\u003e\u003cp\u003eIncreasing the racial and ethnic diversity, as well as global inclusivity of clinical trials for ALM, is especially pertinent given the differences in prevalence and participant demographics worldwide. Improving public awareness of clinical trials, conducting trials in racially and ethnically diverse areas, and addressing the financial and language barriers that limit participation, may increase diverse representation in future studies. Furthermore, improving global inclusivity, specifically in low- or middle-income countries, will also require increased funding and modulations to current regulatory processes that affect clinical trial approval [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Identifying and implementing global and inclusive solutions to these barriers will be essential for improving diversity in future clinical trials for ALM.\u003c/p\u003e"},{"header":"Statement of Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eFS and RPL conceptualized the project. FS, DP, and RPL all contributed to manuscript writing and reviewing.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAdewole T, Albrecht B, Beg S, Brawley O, Chang IF, Daly B et al (2024) Advancing Global Health Equity in Oncology Clinical Trial Access. Cancer Discov 14(12):2317\u0026ndash;2323\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBasurto-Lozada P, Molina‐Aguilar C, Castaneda‐Garcia C, V\u0026aacute;zquez‐Cruz ME, Garcia‐Salinas OI, \u0026Aacute;lvarez‐Cano A et al (2021) Acral lentiginous melanoma: Basic facts, biological characteristics and research perspectives of an understudied disease. Pigment Cell Melanoma Res 34(1):59\u0026ndash;71\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBrunsgaard EK, Wu YP, Grossman D (2023) Melanoma in skin of color: Part I. Epidemiology and clinical presentation. J Am Acad Dermatol 89(3):445\u0026ndash;456\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCarvalho LAD, Aguiar FC, Smalley KSM, Possik PA (2023) Acral melanoma: new insights into the immune and genomic landscape. Neoplasia 46:100947\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDugan MM, Perez MC, Karapetyan L, Zager JS (2024) Management of acral lentiginous melanoma: current updates and future directions. Front Oncol. ;14\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHuang K, Fan J, Misra S (2020) Acral Lentiginous Melanoma: Incidence and Survival in the United States, 2006\u0026ndash;2015, an Analysis of the SEER Registry. J Surg Res 251:329\u0026ndash;339\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eU.S. Census Bureau QuickFacts: United States [Internet]. Washington, D.C: U.S. Census Bureau; Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.census.gov/quickfacts/fact/table/US\u003c/span\u003e\u003cspan address=\"https://www.census.gov/quickfacts/fact/table/US\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"archives-of-dermatological-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Archives of Dermatological Research](https://www.springer.com/journal/403)","snPcode":"403","submissionUrl":"https://submission.nature.com/new-submission/403/3","title":"Archives of Dermatological Research","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Acral lentiginous melanoma, clinical trials, diversity, race, and ethnicity","lastPublishedDoi":"10.21203/rs.3.rs-8097218/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8097218/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eAcral lentiginous melanoma (ALM) is a rare form of cutaneous melanoma (CM) affecting the palm, soles and nailbeds. ALM predominantly affects people with skin of color, and it is the most common form of CM diagnosed in Black populations. Globally, ALM is the predominant CM subtype diagnosed in certain Asian and Latin American countries. Thus, it is imperative that ALM clinical trials reflect the diversity of participants affected. The purpose of this study is to assess racial and ethnic representation in Phase I-IV clinical trials for ALM using The U.S. National Library of Medicine clinical trials database and PubMed. 11 clinical trials with 394 participants were included in our analysis. Nine clinical trials included other melanoma subtypes, as, 39.6% of participants were diagnosed with ALM, 39.3% with mucosal melanoma, and 16.5% with other subtypes or skin conditions. Six clinical trials reported race and ethnicity, and we found that 79.4% of the participants were White, 15.9% were Asian, 3.2% were Black, and 0.5% were reported as more than one race. Only three studies reported ethnicity, in which only 11.30% of participants were Hispanic. Compared to the U.S. Census Bureau and a previously published Surveillance, Epidemiology, and End Results study, White participants were overall highly represented, and racial and ethnic minority participants were underrepresented. Our findings highlight the need for the systematic inclusion of racial and ethnic minority groups and improved demographic reporting in ALM clinical trials.\u003c/p\u003e","manuscriptTitle":"Racial and ethnic representation across acral lentiginous melanoma clinical trials","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-28 06:25:48","doi":"10.21203/rs.3.rs-8097218/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"82341410462240945786986749685151592018","date":"2025-11-24T20:56:46+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-11-24T03:24:14+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-11-14T08:10:41+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-11-14T08:09:20+00:00","index":"","fulltext":""},{"type":"submitted","content":"Archives of Dermatological Research","date":"2025-11-12T14:05:54+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"archives-of-dermatological-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Archives of Dermatological Research](https://www.springer.com/journal/403)","snPcode":"403","submissionUrl":"https://submission.nature.com/new-submission/403/3","title":"Archives of Dermatological Research","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"237e05b6-f0be-42e9-885a-8f1768adcf1d","owner":[],"postedDate":"November 28th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-03-09T22:53:14+00:00","versionOfRecord":[],"versionCreatedAt":"2025-11-28 06:25:48","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8097218","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8097218","identity":"rs-8097218","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}