Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT00134758
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients between 18 and 65 years of age
* Weight less than or equal to 100 kg
* Restorative proctocolectomy
* Activated protein C (APC) mutation identified or more than 100 polyps on the colectomy specimen
* SPIGELMAN score of duodenal adenoma greater than or equal to 1
* Efficient contraceptive treatment for pre-menopausal women
* Cooperative patient
* Signed consent
* Social security insurance
Exclusion Criteria:
* SPIGELMAN score of duodenal adenoma equal to 4 with severe dysplasia
* Hepatic disease
* Intermesenteric desmoid tumour
* Any severe disease
* Daily use during the last 3 months of:
* aspirin;
* non-steroid anti-inflammatory drugs;
* tamoxifen;
* cholestyramine.
* Pregnancy
* Breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00134758
Study Brief:
Protocol Section:
NCT00134758