Intervertebral Disc DegenerationRuDDSNCT04600544
Russian Disc Degeneration Study
An observational study of Intervertebral Disc Degeneration and Genetic Predisposition to Disease, run by Novosibirsk State University at 3 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intervertebral Disc Degeneration, Genetic Predisposition to Disease
- What is being tested?
- Non-interventional
- How many people
- 1,070 participants
- Where
- 3 sitesRussia
- Study dates
- 16 Oct 2020to 10 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Age over 18;
- Presence of lumbar MRI scans;
- Signed informed consent for voluntary participation is provided.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, 127299
Institute of Cytology and Genetics
Novosibirsk, 630090
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a.Ya.L.Tsivyan
Novosibirsk, 630091
About this study
Official title: Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration
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.
- Being tested
- Non-interventional
- Keywords
- biobank, functional genomics, transcriptomics, glycomics
- Medical subject headings
- Intervertebral Disc Degeneration, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Translational, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotyping
DNA will be extracted from the whole blood samples according to the standard protocol
Measured: Through 3 years
Secondary outcomes (3)
Phenotype of patients with lumbar disc degeneration
General information about a patient, his medical history and MRI scans of lumbar spine
Measured: Through 3 years
Total plasma proteins N-glycosylation profiling
The plasma glycans profiling will be performed according to standard protocol
Measured: 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.
Measured: Through 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start16 Oct 2020
- Primary completion19 Oct 2022
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,070 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Novosibirsk State University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600544
- Sponsor's protocol ID
- NS02-04
- Acronym
- RuDDS
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2020
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Leonova O, Elgaeva E, Berdnikova A, Tsepilov Y, Krutko A. Lumbar MRI and Back Pain After Failed Conservative Treatment: The RuDDS Study. Global Spine J. 2026 Mar;16(2):1126-1134. doi: 10.1177/21925682251373046. Epub 2025 Sep 3.
PubMed 40901806Leonova ON, Elgaeva EE, Golubeva TS, Peleganchuk AV, Krutko AV, Aulchenko YS, Tsepilov YA. A protocol for recruiting and analyzing the disease-oriented Russian disc degeneration study (RuDDS) biobank for functional omics studies of lumbar disc degeneration. PLoS One. 2022 May 13;17(5):e0267384. doi: 10.1371/journal.pone.0267384. eCollection 2022.
PubMed 35560143
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease-oriented Russian Disc Degeneration Study (RuDDS) Biobank Facilitating Functional Omics Studies of Lumbar Disc Degeneration
- ClinicalTrials.gov ID
- NCT04600544
- Acronym / sponsor ID
- RuDDS / NS02-04
- Keywords
- biobank, functional genomics, transcriptomics, glycomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- Novosibirsk State UniversityUniversity, hospital or other
- 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
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age over 18;
- Presence of lumbar MRI scans;
- Signed informed consent for voluntary participation is provided.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalTranslational, observational study | Other | – |
Primary outcome
Genotyping
Time frame: Through 3 years
DNA will be extracted from the whole blood samples according to the standard protocol
3 secondary outcomes
Phenotype of patients with lumbar disc degeneration
Time frame: Through 3 years
Total plasma proteins N-glycosylation profiling
Time frame: Through 3 years
Total RNA profiling
Time frame: Through 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 40901806Leonova O, Elgaeva E, Berdnikova A, Tsepilov Y, Krutko A. Lumbar MRI and Back Pain After Failed Conservative Treatment: The RuDDS Study. Global Spine J. 2026 Mar;16(2):1126-1134. doi: 10.1177/21925682251373046. Epub 2025 Sep 3.
- Derived from this study: PubMed 35560143Leonova ON, Elgaeva EE, Golubeva TS, Peleganchuk AV, Krutko AV, Aulchenko YS, Tsepilov YA. A protocol for recruiting and analyzing the disease-oriented Russian disc degeneration study (RuDDS) biobank for functional omics studies of lumbar disc degeneration. PLoS One. 2022 May 13;17(5):e0267384. doi: 10.1371/journal.pone.0267384. eCollection 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration and Genetic Predisposition to Disease, run by Novosibirsk State University at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotyping (time frame: Through 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.