- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06444503
Clinico-biological Collection of Bone, Calcium and Growth Plate Pathologies (OSCAR)
September 23, 2024 updated by: University Hospital, Toulouse
Creation of a Biological Collection to Study the Pathophysiology and Identify Predictive Factors for the Evolution of Bone, Calcium and Growth Plate Pathologies
The aim of this project is to set up a biological and clinical collection of patients with progressive bone, calcium and growth plate pathologies.
This collection will provide a better understanding of the mechanisms involved in growth plate and bone damage in these diseases and identify factors predictive of progression and new therapeutic targets.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas EDOUARD, MD
- Phone Number: +33 0534558555
- Email: edouard.t@chu-toulouse.fr
Study Contact Backup
- Name: Sanaa EDDIRY
- Phone Number: +33 0561776110
- Email: eddiry.s@chu-toulouse.fr
Study Locations
-
-
-
Toulouse, France, 31000
- Recruiting
- University Toulouse Hospital
-
Contact:
- Thomas EDOUARD, MD
-
Contact:
- Thomas EDOUARD, MD
- Phone Number: +33 0534558555
- Email: edouard.t@chu-toulouse.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with with growth plate or bone pathology.
Description
Inclusion Criteria:
- Children (from birth) with growth plate or bone pathology
- Patients affiliated to or benefiting from a social security scheme
- Patients able to receive information about the study and to understand the information form in order to participate in the study. This implies :
- mastery of the French language
- Not being subject to a restriction of rights by the judicial authorities
- Patients or legal representatives having given their consent to participate in the study (expression of non-opposition).
Exclusion Criteria:
- Patients under legal protection (guardianship, curatorship or safeguard of justice)
- Pregnant or breast-feeding women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients suffering from growth plate or bone pathology
As part of their pathology, patients benefit from clinical monitoring and regular blood and urine tests.
|
Surgical residues may be preserved in the event of surgery carried out as part of the treatment.
Blood and urine will be taken in larger quantity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Building a collection of biological samples and clinical-biological data from patients presenting bone, calcium and growth plate pathologies
Time Frame: Day 0 and through study completion, an average of 5 years
|
Blood and urine sampling
|
Day 0 and through study completion, an average of 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identification of potential markers of disease progression based on new knowledge.
Time Frame: Day 0 and through study completion, an average of 5 years
|
Day 0 and through study completion, an average of 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas EDOUARD, MD, CHU Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2024
Primary Completion (Estimated)
September 16, 2034
Study Completion (Estimated)
September 16, 2034
Study Registration Dates
First Submitted
May 30, 2024
First Submitted That Met QC Criteria
May 30, 2024
First Posted (Actual)
June 5, 2024
Study Record Updates
Last Update Posted (Actual)
September 25, 2024
Last Update Submitted That Met QC Criteria
September 23, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/24/0214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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