Russian Disc Degeneration Study

Completed

• Conditions: Intervertebral Disc Degeneration; Genetic Predisposition to Disease

• Registration Number: NCT04600544
• Lead Sponsor: Novosibirsk State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-16
• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Primary Completion: 2022-10-19
• Status Verified: 2024-12
• Study Completion: 2024-12-10
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1070

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genotyping	Through 3 years	DNA will be extracted from the whole blood samples according to the standard protocol

Secondary Outcome Measures

Name	Time	Method
Total RNA profiling	Through 3 years	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.
Total plasma proteins N-glycosylation profiling	Through 3 years	The plasma glycans profiling will be performed according to standard protocol
Phenotype of patients with lumbar disc degeneration	Through 3 years	General information about a patient, his medical history and MRI scans of lumbar spine

Trial Locations

Locations (3)

Priorov National Medical Research Center of Traumatology and Orthopedics; 🇷🇺 Moscow, Russian Federation

Institute of Cytology and Genetics; 🇷🇺 Novosibirsk, Russian Federation

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a.Ya.L.Tsivyan; 🇷🇺 Novosibirsk, Russian Federation