Status:
COMPLETED
Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
National Research Agency, France
Conditions:
Radiation Enteritis
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and c...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Group 1: active IBD
- 18 years old or older
- Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria
- Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis)
- Indication to perform a coloscopy
- Written consent for study participation obtained
- Or
- \- Group 2: inactive IBD
- 18 years old or older
- Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to ECCO 2019 consensus criteria
- Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayo score below 3 for ulcerative colitis)
- Indication to perform a coloscopy
- Written consent for study participation obtained
- Or
- \- Group 3: Control
- 18 years old or older
- Indication to perform a coloscopy to detect polyp
- No known bowel disease
- Written consent for study participation obtained
- Exclusion Criteria:
- Inability to understand, read, sign informed consent and/or express consent
- Person subject to legal protection (curator, guardianship or safeguard of justice),
- Deprivation of liberty by judicial or administrative decision,
- Non-affiliation to a social security scheme or non-beneficiary of such a scheme
- Pregnant, parturient, breastfeeding women
- Contraindication to performing biopsies
- Participation in other therapeutic research that may modify the behavior of intestinal cells (for example, drug research for the treatment of IBD)
- Anticoagulant treatment or bleeding disorder
- Person subject to a judicial safeguard measure
- People hospitalized without consent
Exclusion
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05425901
Start Date
September 19 2022
End Date
December 11 2024
Last Update
September 18 2025
Active Locations (1)
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1
Groupe Hospitalier Ambroise Paré Hartmann
Neuilly-sur-Seine, Hauts-de-Seine, France, 92200