Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

Exact Sciences Corporation

Status: Terminated

Conditions: Digestive System Diseases; Colonic Diseases; Colorectal Neoplasms; Colorectal Cancer

Treatments: Device: Stool Sample Collection Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT02503631

2014-02

Details and patient eligibility

About

The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

Full description

This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.

One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.

Enrollment: 397 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is male or female, 40-90 years of age, inclusive.
• Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
• Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion criteria

• Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
• Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Trial design

397 participants in 1 patient group

Colorectal cancer patients

Description:

Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.

Treatment:

Device: Stool Sample Collection Kit