Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

Colorectal Cancer Clinical Trial

Official title:

Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600209
• Other study ID #: Exact Sciences 2011-N
• Status: Completed
• Phase: N/A
• First received: May 11, 2012
• Last updated: May 12, 2015
• Start date: October 2011
• Est. completion date: September 2012

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 and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.

Description:

Patients who have recently undergone a colonoscopy that resulted with normal findings will be asked to submit a stool sample (s) (at least 30 days AFTER colonoscopy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 84 Years

Eligibility

Inclusion Criteria:

• Subject is male or female, 50-84 years of age, inclusive.

• Subject is at average risk for development of CRC and has undergone a screening colonoscopy with a normal result at least 30 days and no more than 120 days before providing a stool sample for the study. For the purposes of this study, a "normal" colonoscopy result is defined as no polyps of any size detected or removed (including benign, hyperplastic polyps).

• Subject is able to understand the study procedures, and is able to provide signed consent to participate in the study and authorizes release of relevant protected health information through signing a HIPAA consent.

• Subject is able and willing to provide stool samples at least 30 days and no more than 120 days after undergoing a colonoscopy that resulted in normal findings, according to the written instructions provided to them.

Exclusion Criteria:

• Subject has any condition which, in the opinion of the investigator should preclude participation in the study.

• Subject had any findings on recent or any previous colonoscopy including benign, and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no histopathology findings are acceptable.)

• Subject has a history or recent diagnosis of CRC or adenoma.

• Subject has a history of aerodigestive tract cancer.

• Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.

• Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.

• Subject has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)

• Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:

• Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.

• Greater than or equal to (>=)2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).

• One first-degree relative with CRC diagnosed before the age of 60.

• Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).

• Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome").

• Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.

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
United States	Professional Quality Research, Inc.	Austin	Texas
United States	Columbia Medical Practice	Columbia	Maryland
United States	Atlanta Gastroenterology Associates	Marietta	Georgia
United States	New Orleans Research Institue	Metairie	Louisiana
United States	Miami Research Associates	Miami	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	Main Line Gastroenterology	Perkasie	Pennsylvania
United States	Remek Research	Pomona	California
United States	Rockford Gastroenterology Associates, LTD.	Rockford	Illinois
United States	Sharp Rees-Stealy	San Diego	California
United States	Advanced Research Institute	Sandy	Utah
United States	Southern California Medical Gastroenterology Group, Inc	Santa Monica	California
United States	Desert Sun Clinical Research	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

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	Sensitivity and Specificity of the Exact CRC diagnostic screening test.	The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.	10 months	No