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Russian Disc Degeneration Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04600544
Acronym
RuDDS
Enrollment
1070
Registered
2020-10-23
Start date
2020-10-16
Completion date
2024-12-10
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Predisposition to Disease, Intervertebral Disc Degeneration

Keywords

biobank, functional genomics, transcriptomics, glycomics

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.

Interventions

OTHERNon-interventional

Translational, observational study

Sponsors

Institute of Cytology and Genetics
CollaboratorUNKNOWN
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
CollaboratorOTHER_GOV
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
CollaboratorOTHER
Novosibirsk State University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
GenotypingThrough 3 yearsDNA will be extracted from the whole blood samples according to the standard protocol

Secondary

MeasureTime frameDescription
Phenotype of patients with lumbar disc degenerationThrough 3 yearsGeneral information about a patient, his medical history and MRI scans of lumbar spine
Total plasma proteins N-glycosylation profilingThrough 3 yearsThe plasma glycans profiling will be performed according to standard protocol
Total RNA profilingThrough 3 yearsThe 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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026