Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

Completed

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

• Registration Number: NCT01260168
• Lead Sponsor: Exact Sciences Corporation

Brief Summary

The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer.

Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.

Detailed Description

Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

Inclusion Criteria

1. Subject is male or female, 40-90 years of age, inclusive.
2. Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria

1. Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
2. Subject has a history of any inflammatory bowel disease.
3. Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.	12 Months	The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.

Secondary Outcome Measures

Name	Time	Method
To collect samples from patients diagnosed with colorectal cancers.	12 Months	Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the sponsor.

Trial Locations

Locations (21)

Clinical Research Associates; 🇺🇸 Huntsville, Alabama, United States

Long Island Gastrointestinal Group; 🇺🇸 Great Neck, New York, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Asheville Gastroenterology; 🇺🇸 Asheville, North Carolina, United States

Southern Gastroenterology Associates; 🇺🇸 New Bern, North Carolina, United States

Gastro One; 🇺🇸 Germantown, Tennessee, United States

Digestive Health Specialists; 🇺🇸 Tyler, Texas, United States

Gastroenterology Associates; 🇺🇸 Baton Rouge, Louisiana, United States

Commonwealth Clinical Studies; 🇺🇸 Brockton, Massachusetts, United States

Rockford Gastroenterology Associates, Ltd; 🇺🇸 Rockford, Illinois, United States

Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

Digestive and Liver Disease Specialists; 🇺🇸 Norfolk, Virginia, United States

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Achieve Clinical Research, LLC; 🇺🇸 Birmingham, Alabama, United States

Atlanta Gastroenterology; 🇺🇸 Atlanta, Georgia, United States

Jesse Brown VA; 🇺🇸 Chicago, Illinois, United States

Rush University Gastroenterologists; 🇺🇸 Chicago, Illinois, United States

Stroger Cook County; 🇺🇸 Chicago, Illinois, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Northwest Gastroenterology Clinic, LLC; 🇺🇸 Portland, Oregon, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States