The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Russian Disc Degeneration Study (RuDDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04600544
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 25, 2023
Sponsor:
Collaborators:
Institute of Cytology and Genetics
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Information provided by (Responsible Party):
Novosibirsk State University

Tracking Information
First Submitted Date October 19, 2020
First Posted Date October 23, 2020
Last Update Posted Date October 25, 2023
Actual Study Start Date October 16, 2020
Actual Primary Completion Date October 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2021)		 Genotyping [ Time Frame: Through 3 years ]
DNA will be extracted from the whole blood samples according to the standard protocol
Original Primary Outcome Measures
 (submitted: October 19, 2020)		 Genotype of patients with lumbar disc degeneration. [ Time Frame: Through 2 years ]
DNA extracted from the blood samples for genotyping using SNP arrays
Change History
Current Secondary Outcome Measures
 (submitted: March 5, 2021)
  • Phenotype of patients with lumbar disc degeneration [ Time Frame: Through 3 years ]
    General information about a patient, his medical history and MRI scans of lumbar spine
  • Total plasma proteins N-glycosylation profiling [ Time Frame: Through 3 years ]
    The plasma glycans profiling will be performed according to standard protocol
  • Total RNA profiling [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: October 19, 2020)
  • Phenotype of patients with lumbar disc degeneration [ Time Frame: Through 2 years ]
    Grade of lumbar disc degeneration by MRI
  • Expression profile of intraoperative samples [ Time Frame: Through 2 years ]
    Total RNA using RNA-seq technology
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Russian Disc Degeneration Study
Official Title Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Retention:   Samples With DNA
Description:
Whole blood samples, plasma. Intervertebral lumbar disc samples only for patients subjected for surgery.
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.
Condition
  • Intervertebral Disc Degeneration
  • Genetic Predisposition to Disease
Intervention Other: Non-interventional
Translational, observational study
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 5, 2021)		 1100
Original Estimated Enrollment
 (submitted: October 19, 2020)		 1200
Estimated Study Completion Date January 19, 2025
Actual Primary Completion Date October 19, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Olga Leonova, PhD, MD +7 (383) 373-32-01 onleonova@gmail.com
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04600544
Other Study ID Numbers NS02-04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: During the study conducting and 5 years after
Access Criteria: Contact the Central Contact Person onleonova@gmail.com
Current Responsible Party Novosibirsk State University
Original Responsible Party Same as current
Current Study Sponsor Novosibirsk State University
Original Study Sponsor Same as current
Collaborators
  • Institute of Cytology and Genetics
  • Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
  • N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Investigators Not Provided
PRS Account Novosibirsk State University
Verification Date October 2023