- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07782203
Establishment of a Biological Collection to Develop Translational Preclinical Models for the Study of Tumors and Diseases of the Gastrointestinal Tract (GIMod)
The causes underlying the development of chronic inflammatory bowel diseases (IBD) and digestive cancers remain poorly understood. They involve both genetic susceptibilities and multiple environmental factors.
Research and the development of new therapeutic strategies are essential to provide patients with novel treatment opportunities. A deep understanding of the tumor ecosystem at the molecular level, as well as the interactions between different cell types, is crucial to identify and validate new therapeutic targets.
Since animal cancer models have shown their limitations in translating results to humans, studies models are often based on autologous patient tissues and sera. These innovative models make it possible to:
- model tumors ex vivo,
- perform screenings of new candidate molecules,
- or test tumor response to existing therapies in the context of personalized medicine.
This work has led to numerous publications on advanced digestive cancers, such as those of the liver or the bile acid pathway To create ex vivo models and reconstruct the tumor in vitro, experiments require treating tumor cells with blood from the same patient (autologous), collected simultaneously with the tumor resection. The tumor tissues used in culture are obtained from residual material of anatomopathological analyses performed as part of clinical care.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas BAUMERT
- Phone Number: 0033368853703
- Email: thomas.baumert@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67000
- Recruiting
- Hôpitaux Universitaires de Strasbourg
-
Contact:
- Thomas BAUMERT
- Phone Number: 0368853703
- Email: thomas.baumert@chru-strasbourg.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with IBD and for whom a digestive endoscopy +/- echo-endoscopy or gastrointestinal tract surgery is planned as part of care.
- Diagnosed with digestive tract cancer on IBD and for whom a digestive endoscopy +/- echo-endoscopy or gastrointestinal tract surgery is planned as part of care.
- Diagnosed with digestive cancer (esophagus, stomach, colon/rectum) and for whom a digestive endoscopy +/- echo-endoscopy or gastrointestinal tract surgery is planned as part of care.
- Diagnosed with Barrett's esophagus and for whom a digestive endoscopy +/- echo-endoscopy or gastrointestinal tract surgery is planned as part of care
Exclusion Criteria:
- All other
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: gastrointestinal surgery indicated
Patients for whom gastrointestinal surgery is indicated in the context of IBD or suspected gastrointestinal cancer (esophagus, stomach, colon/rectum
|
collect tissues and blood cell
|
|
Other: gastrointestinal endoscopy planned for IBD
Patients for whom gastrointestinal endoscopy is planned in the context of suspected or follow-up of IBD
|
collect tissues and blood cell
|
|
Other: gastrointestinal endoscopy planned for cancer
Patients for whom gastrointestinal endoscopy is planned in the context of suspected gastrointestinal cancer
|
collect tissues and blood cell
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of tissue samples suitable for cell culture procedures
Time Frame: At the time of surgery or digestive endoscopy
|
Number of tissue samples collected from eligible participants during routine surgical procedures or digestive endoscopy and considered suitable for the cell culture procedures defined in the study protocol.
The collected tissue samples will contribute to a biological collection intended for fundamental research on the development of tumors and diseases of the gastrointestinal tract.
|
At the time of surgery or digestive endoscopy
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastrointestinal Neoplasms
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Cytological Techniques
- Cytodiagnosis
- Diagnostic Techniques, Surgical
- Biopsy
Other Study ID Numbers
- 9681 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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