Russian Disc Degeneration Study (RuDDS)
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ClinicalTrials.gov Identifier: NCT04600544 |
Recruitment Status :
Recruiting
First Posted : October 23, 2020
Last Update Posted : October 25, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Intervertebral Disc Degeneration Genetic Predisposition to Disease | Other: Non-interventional |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 1100 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Months |
Official Title: | Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration |
Actual Study Start Date : | October 16, 2020 |
Actual Primary Completion Date : | October 19, 2022 |
Estimated Study Completion Date : | January 19, 2025 |
- Other: Non-interventional
Translational, observational study
- Genotyping [ Time Frame: Through 3 years ]DNA will be extracted from the whole blood samples according to the standard protocol
- 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.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age over 18;
- Presence of lumbar MRI scans;
- Signed informed consent for voluntary participation is provided.
Exclusion Criteria:
- Any contraindication or inability to undergo baseline procedures;
- Prior surgeries at any level of the lumbar spine;
- Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduction of the study;
- History or presence of HIV, hepatitis B, hepatitis C.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600544
Contact: Olga Leonova, PhD, MD | +7 (383) 373-32-01 | onleonova@gmail.com |
Russian Federation | |
Priorov National Medical Research Center of Traumatology and Orthopedics | Not yet recruiting |
Moscow, Russian Federation, 127299 | |
Contact: Aleksandr Krutko, PhD, MD +7 (499) 940-97-47 ortho-ped@mail.ru | |
Institute of Cytology and Genetics | Recruiting |
Novosibirsk, Russian Federation, 630090 | |
Contact: Yakov Tsepilov, PhD +7 (383) 363-49-86 tsepilov@bionet.nsc.ru | |
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a.Ya.L.Tsivyan | Recruiting |
Novosibirsk, Russian Federation, 630091 | |
Contact: Olga Leonova, PhD, MD +7 (383) 373-32-01 onleonova@gmail.com |
Responsible Party: | Novosibirsk State University |
ClinicalTrials.gov Identifier: | NCT04600544 |
Other Study ID Numbers: |
NS02-04 |
First Posted: | October 23, 2020 Key Record Dates |
Last Update Posted: | October 25, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (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 Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | During the study conducting and 5 years after |
Access Criteria: | Contact the Central Contact Person onleonova@gmail.com |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
biobank functional genomics transcriptomics glycomics |
Intervertebral Disc Degeneration Genetic Predisposition to Disease Disease Susceptibility Disease Attributes |
Pathologic Processes Spinal Diseases Bone Diseases Musculoskeletal Diseases |