Clinical trial NCT01600209: Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
Official title: Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer
Keywords: Cancer
Colorectal Cancer
Neoplasm
Colorectal Neoplasm
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2012-05-17
Enrollment: 674
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are at average risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and Specificity of the Exact CRC diagnostic screening test.
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Desert Sun Clinical Research
state: Arizona
city: Pomona
country: United States
facility: Remek Research
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy
state: California
city: Santa Monica
country: United States
facility: Southern California Medical Gastroenterology Group, Inc
state: California
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Marietta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, LTD.
state: Illinois
city: Metairie
country: United States
facility: New Orleans Research Institue
state: Louisiana
city: Columbia
country: United States
facility: Columbia Medical Practice
state: Maryland
city: Perkasie
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Austin
country: United States
facility: Professional Quality Research, Inc.
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Sandy
country: United States
facility: Advanced Research Institute
state: Utah
Study officials:
affiliation: Chief Scientific Officer
name: Graham Lidgard, PhD
role: STUDY_CHAIR
References:
citation: 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 neoplasia. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1313-8. doi: 10.1016/j.cgh.2013.04.023. Epub 2013 Apr 29.