Russian Disc Degeneration Study

NCT04600544 | Completed

• 1 other identifier: NS02-04
• Study Type: observational
• Target: 1,070
• Locations: 1 country
• Sites: 3

Brief Summary

The main aim of this study is to establish disease-oriented biobank to facilitate research in biology of the lumbar disc degeneration. Diverse biological samples (whole blood, plasma, disc tissue) along with MRI imaging, clinical, socio-demographic and various omics data (e.g. genomic and transcriptomic) will be available for researchers and clinicians for a variety of further multi-omics studies. It will lay the groundwork for the development of early diagnostics of DDD and its personalized treatment. The study is planned to enroll up to 1,100 patients with different grades of lumbar disc degeneration. It is planned to recruit patients within 36 months.

Conditions

Intervertebral Disc Degeneration; Genetic Predisposition to Disease

Keywords

biobank; functional genomics; transcriptomics; glycomics

Outcome Measures

Primary Outcomes (1)

• Genotyping

  DNA will be extracted from the whole blood samples according to the standard protocol

  Through 3 years

Secondary Outcomes (3)

• Phenotype of patients with lumbar disc degeneration

  Through 3 years

• Total plasma proteins N-glycosylation profiling

  Through 3 years

• Total RNA profiling

  Through 3 years

Interventions

Non-interventional OTHER

Translational, observational study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged over 18 with available MRI scans of lumbar spine, who will also sign an informed consent and meet all the eligibility criteria.

You may qualify if:

• Age over 18;
• Presence of lumbar MRI scans;
• Signed informed consent for voluntary participation is provided.

You may not qualify if:

• Any contraindication or inability to undergo baseline procedures;
• Prior surgeries at any level of the lumbar spine;
• Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduction of the study;
• History or presence of HIV, hepatitis B, hepatitis C.

Sponsors & Collaborators

• Novosibirsk State University: lead
• Institute of Cytology and Genetics: collaborator
• Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan: collaborator
• N.N. Priorov National Medical Research Center of Traumatology and Orthopedics: collaborator

Study Sites (3)

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

Location

Institute of Cytology and Genetics

Novosibirsk, 630090, Russia

Location

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a.Ya.L.Tsivyan

Novosibirsk, 630091, Russia

Location

Related Publications (2)

• Leonova O, Elgaeva E, Berdnikova A, Tsepilov Y, Krutko A. Lumbar MRI and Back Pain After Failed Conservative Treatment: The RuDDS Study. Global Spine J. 2025 Sep 3:21925682251373046. doi: 10.1177/21925682251373046. Online ahead of print.

  PMID: 40901806 DERIVED

• Leonova ON, Elgaeva EE, Golubeva TS, Peleganchuk AV, Krutko AV, Aulchenko YS, Tsepilov YA. A protocol for recruiting and analyzing the disease-oriented Russian disc degeneration study (RuDDS) biobank for functional omics studies of lumbar disc degeneration. PLoS One. 2022 May 13;17(5):e0267384. doi: 10.1371/journal.pone.0267384. eCollection 2022.

  PMID: 35560143 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples, plasma. Intervertebral lumbar disc samples only for patients subjected for surgery.

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: October 16, 2020
• Primary Completion: October 19, 2022
• Study Completion: December 10, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: During the study conducting and 5 years after
• Access Criteria: Contact the Central Contact Person onleonova@gmail.com

Locations

RU (3)