Russian Disc Degeneration Study

Novosibirsk State University1,070 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,070

Conditions

Intervertebral Disc Degeneration Genetic Predisposition to Disease

Interventions

Non-interventionalOTHER

Translational, observational study

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (3)

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, Russia

Institute of Cytology and Genetics

Novosibirsk, Russia

Novosibirsk Research Institute of Traumatology and Orthopaedics n.a.Ya.L.Tsivyan

Novosibirsk, Russia

Outcomes

Primary Outcomes

Genotyping

DNA will be extracted from the whole blood samples according to the standard protocol

Time frame: Through 3 years

Secondary Outcomes

Phenotype of patients with lumbar disc degeneration

General information about a patient, his medical history and MRI scans of lumbar spine

Time frame: Through 3 years

Total plasma proteins N-glycosylation profiling

The plasma glycans profiling will be performed according to standard protocol

Time frame: Through 3 years

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.

Time frame: Through 3 years