Russian Disc Degeneration Study (RuDDS)

Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration

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.

Study Overview

• Status: Completed
• Conditions: Genetic Predisposition to Disease; Intervertebral Disc Degeneration
• Intervention / Treatment: Other: Non-interventional

• Study Type: Observational
• Enrollment (Actual): 1070

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 127299
    • Priorov National Medical Research Center of Traumatology and Orthopedics
  • Novosibirsk, Russian Federation, 630090
    • Institute of Cytology and Genetics
  • Novosibirsk, Russian Federation, 630091
    • Novosibirsk Research Institute of Traumatology and Orthopaedics n.a.Ya.L.Tsivyan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genotyping	DNA will be extracted from the whole blood samples according to the standard protocol	Through 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenotype of patients with lumbar disc degeneration	General information about a patient, his medical history and MRI scans of lumbar spine	Through 3 years
Total plasma proteins N-glycosylation profiling	The plasma glycans profiling will be performed according to standard protocol	Through 3 years
Total RNA profiling	The intraoperative material will be homogenized and total RNA will be extracted and converted to cDNA using Kit for the isolation of total RNA and microRNA from cells and tissues and M-MuLV-RH First Strand cDNA Synthesis Kit respectively. The amount of extracted RNA and its quality will be estimated using Bioanalyzer 2100.	Through 3 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: biobank; transcriptomics; functional genomics; glycomics
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Disease Attributes; Spinal Diseases; Disease Susceptibility; Intervertebral Disc Degeneration; Genetic Predisposition to Disease
• Other Study ID Numbers: NS02-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To access the database, omcis data and other relevant information, projects should be submitted to the steering committee (contact the Central Contact Person) of the RuDDS.
• IPD Sharing Time Frame: During the study conducting and 5 years after
• IPD Sharing Access Criteria: Contact the Central Contact Person onleonova@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No