Neuromuscular DiseasesCOLMYONEUNCT06074822
Research Biobank From Neuromuscular Biopsy Residues (in the Context of Care)
An observational study of Neuromuscular Diseases and Muscle, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Neuromuscular diseases are rare diseases for which significant progress has been made in the context of diagnosis thanks to advances in molecular techniques, but the intimate mechanisms of lesion formation remain poorly understood. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuromuscular Diseases, Muscle, Nerve
- What is being tested?
- Residual neuromuscular biopsy
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2023to 25 Jun 2053
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with neuromuscular symptoms.
Who may be able to join
- Patients treated at Bordeaux University Hospital (neurology services, neuropediatrics), rheumatology, medical genetics for suspected neuromuscular disease.
- Men and women are affected, adults and minors.
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Université Hospital, Bordeaux
Bordeaux, 33000
Marie Laure NEGRIER, Pr, 0557821818 ext. +33, marie-laure.martin-negrier@chu-bordeaux.fr
About this study
Official title: Constitution of a Collection of Residues of Neuromuscular Biopsies From Patients Taken as Part of Their Health Care at the Bordeaux University Hospital for Neuromuscular Disease and Use for Research Projects
Neuromuscular diseases are rare diseases for which significant progress has been made in the context of diagnosis thanks to advances in molecular techniques, but the intimate mechanisms of lesion formation remain poorly understood. Advances in cellular and molecular biology, the development of a few animal models, such as transgenic mice, which make it possible to mimic human pathology have made it possible to better understand the physiopathology of these diseases. However, they still do so very imperfectly and incompletely, making it even more necessary than ever to study diseased human muscle tissue to find new avenues of research or to confirm results obtained by experimentation.
The purpose of this collection of tissue samples for neuro-muscular purposes is to collect such samples under the best conditions in order to promote basic and translational research on muscle diseases.
This is why the CHU de Bordeaux wishes to keep the remainders of samples taken as part of the treatment to constitute a collection of biological samples and associated data kept according to quality standards and in compliance with the regulations in force.
Read the detailed description
The "COLMYONEU" project is a project to collect leftover frozen neuromuscular biopsy samples from patients taken as part of their health care at the Bordeaux University Hospital for neuromuscular disease.
Its main objective is to store, under the conditions of the CRB standard, residual biological samples from patients with neuromuscular symptoms.
- Conditions
- Neuromuscular Diseases, Muscle, Nerve
- Being tested
- Residual neuromuscular biopsy
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residual neuromuscular biopsyOther
recovery of residual neuromuscular biopsy (nerve ans muscle)
| Study group | Role | What they receive |
|---|---|---|
| Constitution of biocollection | Collection of remains of neuromuscular biopsy samples (nerve and muscles) Receives: Other: Residual neuromuscular biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constitution of a biocollection
Collection of leftover frozen neuromuscular biopsy samples from patients taken as part of their health care at the Bordeaux University Hospital for neuromuscular disease.
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start26 Jun 2023
- Primary completion25 Jun 2053 (estimated)
- Study completion25 Jun 2053 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Laure NEGRIER, Pr, Principal investigator, Université Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074822
- Sponsor's protocol ID
- CHUBX 2023/26
- Acronym
- COLMYONEU
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution of a Collection of Residues of Neuromuscular Biopsies From Patients Taken as Part of Their Health Care at the Bordeaux University Hospital for Neuromuscular Disease and Use for Research Projects
- ClinicalTrials.gov ID
- NCT06074822
- Acronym / sponsor ID
- COLMYONEU / CHUBX 2023/26
- Conditions
- Neuromuscular Diseases, Muscle, Nerve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 25 Jun 2053 (estimated)
- Study completion
- 25 Jun 2053 (estimated)
- First posted
- 10 Oct 2023 (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.
Neuromuscular diseases are rare diseases for which significant progress has been made in the context of diagnosis thanks to advances in molecular techniques, but the intimate mechanisms of lesion formation remain poorly understood. Advances in cellular and molecular biology, the development of a few animal models, such as transgenic mice, which make it possible to mimic human pathology have made it possible to better understand the physiopathology of these diseases. However, they still do so very imperfectly and incompletely, making it even more necessary than ever to study diseased human muscle tissue to find new avenues of research or to confirm results obtained by experimentation.
The purpose of this collection of tissue samples for neuro-muscular purposes is to collect such samples under the best conditions in order to promote basic and translational research on muscle diseases.
This is why the CHU de Bordeaux wishes to keep the remainders of samples taken as part of the treatment to constitute a collection of biological samples and associated data kept according to quality standards and in compliance with the regulations in force.
Detailed description
The "COLMYONEU" project is a project to collect leftover frozen neuromuscular biopsy samples from patients taken as part of their health care at the Bordeaux University Hospital for neuromuscular disease.
Its main objective is to store, under the conditions of the CRB standard, residual biological samples from patients with neuromuscular symptoms.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Constitution of biocollection | – | Other: Residual neuromuscular biopsyCollection of remains of neuromuscular biopsy samples (nerve and muscles) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with neuromuscular symptoms.
Key inclusion criteria (2 listed)
- Patients treated at Bordeaux University Hospital (neurology services, neuropediatrics), rheumatology, medical genetics for suspected neuromuscular disease.
- Men and women are affected, adults and minors.
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| Residual neuromuscular biopsyrecovery of residual neuromuscular biopsy (nerve ans muscle) | Other | Constitution of biocollection |
Primary outcome
Constitution of a biocollection
Time frame: 30 years
Collection of leftover frozen neuromuscular biopsy samples from patients taken as part of their health care at the Bordeaux University Hospital for neuromuscular disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Related trials for Neuromuscular Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
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.
Marie Laure NEGRIER, Pr principal investigator
Université Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and Muscle, run by University Hospital, Bordeaux at 1 site in France.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Laure NEGRIER, Pr (0557821818 ext. +33, marie-laure.martin-negrier@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constitution of a biocollection (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023.