NCT02503631

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 397 (actual)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Colorectal Neoplasms
• Digestive System Diseases
• Colonic Diseases
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Stool Sample Collection Kit	Stool sample collection kit

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-03-01
• Completion: 2017-09-01
• First posted: 2015-07-21
• Last updated: 2018-04-06

Locations

22 sites across 2 countries: United States, Canada