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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04600544
Other study ID # NS02-04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 16, 2020
Est. completion date January 19, 2025

Study information

Verified date October 2023
Source Novosibirsk State University
Contact Olga Leonova, PhD, MD
Phone +7 (383) 373-32-01
Email onleonova@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1100
Est. completion date January 19, 2025
Est. primary completion date October 19, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-interventional
Translational, observational study

Locations

Country Name City State
Russian Federation Priorov National Medical Research Center of Traumatology and Orthopedics Moscow
Russian Federation Institute of Cytology and Genetics Novosibirsk
Russian Federation Novosibirsk Research Institute of Traumatology and Orthopaedics n.a.Ya.L.Tsivyan Novosibirsk

Sponsors (4)

Lead Sponsor Collaborator
Novosibirsk State University Institute of Cytology and Genetics, N.N. Priorov National Medical Research Center of Traumatology and Orthopedics, Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Genotyping DNA will be extracted from the whole blood samples according to the standard protocol Through 3 years
Secondary Phenotype of patients with lumbar disc degeneration General information about a patient, his medical history and MRI scans of lumbar spine Through 3 years
Secondary Total plasma proteins N-glycosylation profiling The plasma glycans profiling will be performed according to standard protocol Through 3 years
Secondary Total RNA profiling 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. Through 3 years
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