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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260168
• Other study ID #: Exact Sciences 2010-A
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: May 12, 2015
• Start date: October 2010
• Est. completion date: November 2013

Study information

• Verified date: May 2015
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
United States	Asheville Gastroenterology	Asheville	North Carolina
United States	Atlanta Gastroenterology	Atlanta	Georgia
United States	Gastroenterology Associates	Baton Rouge	Louisiana
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
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	Gastro One	Germantown	Tennessee
United States	Long Island Gastrointestinal Group	Great Neck	New York
United States	Clinical Research Associates	Huntsville	Alabama
United States	Southern Gastroenterology Associates	New Bern	North Carolina
United States	Mount Sinai School of Medicine	New York	New York
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Northwest Gastroenterology Clinic, LLC	Portland	Oregon
United States	Rockford Gastroenterology Associates, Ltd	Rockford	Illinois
United States	University of Utah	Salt Lake City	Utah
United States	Digestive Health Specialists	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Lidgard GP, Domanico MJ, Bruinsma JJ, Light J, Gagrat ZD, Oldham-Haltom RL, Fourrier KD, Allawi H, Yab TC, Taylor WR, Simonson JA, Devens M, Heigh RI, Ahlquist DA, Berger BM. Clinical performance of an automated stool DNA assay for detection of colorectal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.	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.	12 Months	No
Secondary	To collect samples from patients diagnosed with colorectal cancers.	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.	12 Months	No