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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 : March 9, 2021
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

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.


Condition or disease Intervention/treatment
Intervertebral Disc Degeneration Genetic Predisposition to Disease Other: Non-interventional

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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
Estimated Primary Completion Date : October 19, 2022
Estimated Study Completion Date : January 19, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Non-interventional
    Translational, observational study


Primary Outcome Measures :
  1. Genotyping [ Time Frame: Through 3 years ]
    DNA will be extracted from the whole blood samples according to the standard protocol


Secondary Outcome Measures :
  1. 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

  2. Total plasma proteins N-glycosylation profiling [ Time Frame: Through 3 years ]
    The plasma glycans profiling will be performed according to standard protocol

  3. 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
Whole blood samples, plasma. Intervertebral lumbar disc samples only for patients subjected for surgery.


Information from the National Library of Medicine

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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
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.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Olga Leonova, PhD, MD +7 (383) 373-32-01 onleonova@gmail.com

Locations
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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   
Sponsors and Collaborators
Novosibirsk State University
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
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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: March 9, 2021
Last Verified: March 2021
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novosibirsk State University:
biobank
functional genomics
transcriptomics
glycomics
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases