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:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT01819766
Eligibility Criteria:
Inclusion Criteria:
* Male or female 18-84 years of age, inclusive.
* Diagnosis of IBD or a diagnosis of PSC with IBD prior to enrollment date of this study.
* Must be a candidate for a surveillance colonoscopy, with the intention of CRC/dysplasia surveillance, or a candidate for surgical intervention based on prior histological confirmation of HGD or CRC.
* Written informed consent document signed and dated by the subject or legally acceptable representative.
Exclusion Criteria:
* Any condition that in the opinion of the investigator should preclude participation in the study.
* A history of aerodigestive tract cancer.
* Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
* IBD limited only to the rectum and without a concurrent PSC diagnosis.
* Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may be, introduced into the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT01819766
Study Brief:
Protocol Section:
NCT01819766