Clinical trial NCT04600544: Russian Disc Degeneration Study
Official title: Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervertebral Disc Degeneration
Genetic Predisposition to Disease
Keywords: biobank
functional genomics
transcriptomics
glycomics
Lead sponsor: Novosibirsk State University
Sponsor class: OTHER
Collaborators: name: Institute of Cytology and Genetics
name: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
name: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
First posted: 2020-10-23
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Genotyping
timeFrame: Through 3 years
Secondary outcomes:
measure: Phenotype of patients with lumbar disc degeneration
timeFrame: Through 3 years
measure: Total plasma proteins N-glycosylation profiling
timeFrame: Through 3 years
measure: Total RNA profiling
timeFrame: Through 3 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Priorov National Medical Research Center of Traumatology and Orthopedics
city: Novosibirsk
country: Russian Federation
facility: Institute of Cytology and Genetics
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Traumatology and Orthopaedics n.a.Ya.L.Tsivyan
Study officials:
References:
citation: 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.