Protocol for disease-oriented Russian disc degeneration study (RuDDS) biobank facilitating functional omics studies of lumbar disc degeneration

ABSTRACT Introduction Lumbar intervertebral disc degeneration (DD) disease is one of the main risk factors for low back pain. The social and economic importance of low back pain is very high: back pain is among the leading causes of absenteeism and the cost of treating back pain exceeds the cost of treatment of many other serious diseases (cancer, in particular); however, therapy does not always provide the desired result. Despite the variability of biological studies of lumbar DD, it is still not fully understood, partially due to the fact that there are only few studies using systematic and integrative approaches. Hence, more integrative omics studies are needed to link all pieces of knowledge together, build a complete picture of biology of lumbar DD and obtain a deeper understanding of the processes underlying this pathology. Methods and analysis This disease-oriented biobank to study lumbar disc degeneration will be recruited from two clinical centers. A total of 1100 participants with available lumbar MRI will be enrolled during the three-year period. General information about a patient, medical history, lumbar MRI parameters and biological material (whole blood and plasma) will be collected in the centers at baseline. Then, from those patients, who will undergo a spine surgery during the treatment, disc tissue samples will be gained. Eventually, postoperative clinical data will be collected from operated patients during the follow-up. Ethics and dissemination The study will be performed according to the Helsinki Declaration. The study protocol was approved by the Local Ethical Committee of NRITO (№034/20 dated 02 Oct 2020) and by the Local Ethical Committee of Priorov CITO (№1/21 dated 25 Feb 2021). Preliminary and final results will be presented in peer-reviewed journals, at national and international congresses. Trial registration number NCT04600544 ARTICLE SUMMARY STRENGTHS AND LIMITATIONS OF THIS STUDY Two-center and multiple-discipline study: the study includes two centers (Moscow in the European and Novosibirsk in the Asian part of Russia), with research teams specializing in following fields: (1) clinical aspects of lumbar disc degeneration disease, (2) biology and genetics of pain, (3) generation of omics data and (4) multi-omics data analysis Collection of variable biological material: whole blood, plasma and, for part of the participants, intraoperative material of the lumbar disc (with different DD status) will be available for omics studies Objective: diagnosis: lumbar DD status is confirmed by MRI, not self-reported diagnosis Sample size is limited compared to nationwide biobanks Patients with severe lumbar DD status will be more prevalent in the biobank than these with mild or no lumbar DD compared to the general population