Russian Disc Degeneration Study

Genetic Predisposition to Disease Clinical Trial

— RuDDS  

Official title:

Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600544
• Other study ID #: NS02-04
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Genetic Predisposition to Disease
• Intervertebral Disc Degeneration

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