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Completed

NCT Number: NCT04600544

Russian Disc Degeneration Study

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.

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Key information

Conditions

Intervertebral Disc Degeneration Bone Diseases Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Priorov National Medical Research Center of Traumatology and Orthopedics, Moscow, Russia

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

Translational, observational study

Primary outcomes

  1. Genotyping

    Time frame: Through 3 years

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novosibirsk State University

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: RuDDS

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Oct 23, 2020
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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