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Russian Disc Degeneration Study

NCT ID: NCT04600544

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1070 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-16

Study Completion Date

2024-12-10

Brief Summary

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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

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Conditions

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Intervertebral Disc Degeneration Genetic Predisposition to Disease

Keywords

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biobank functional genomics transcriptomics glycomics

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Non-interventional

Translational, observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Cytology and Genetics

UNKNOWN

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role collaborator

N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

OTHER

Sponsor Role collaborator

Novosibirsk State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, , Russia

Site Status

Institute of Cytology and Genetics

Novosibirsk, , Russia

Site Status

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

Novosibirsk, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type DERIVED
PMID: 40901806 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35560143 (View on PubMed)

Other Identifiers

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NS02-04

Identifier Type: -

Identifier Source: org_study_id