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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02503631
• Other study ID #: 2014-02
• Status: Terminated
• First received: July 17, 2015
• Last updated: April 4, 2018
• Start date: October 2014
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 397
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Stool Sample Collection Kit
Stool sample collection kit

Locations

Country	Name	City	State
Canada	Forzani & MacPhali Colon Cancer Screening Centre	Calgary	Alberta
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	DBA Boone Hospital Center	Columbia	Missouri
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Gastro One	Germantown	Tennessee
United States	Medical Research Center of Connecticut	Hamden	Connecticut
United States	Gulf Coast Research Group, LLC	Holiday	Florida
United States	Blue Ridge Medical Researcj	Lynchburg	Virginia
United States	Main Line Gastroenterology Associates	Malvern	Pennsylvania
United States	Colon and Rectal Surgery Associates	Metairie	Louisiana
United States	New Orleans Research Institute	Metairie	Louisiana
United States	John D. Homan, MD	Newport Beach	California
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Endoscopic Research, Inc.	Orlando	Florida
United States	Northwest Gastroenterology Clinic, LLC	Portland	Oregon
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Louisiana Research Center, LLC	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide stool and blood specimens to assess new markers for the detection of CRC		33 months
Secondary	To provide stool and blood specimens for use as controls when assessing new markers for the detection of neoplasms in other locations within the digestive tract (esophagus, stomach, pancreas, etc.)		33 months
Secondary	To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development		33 months
Secondary	To provide quality control material for use in assessing performance of developed assays		33 months