exact crc screening test: stool sample collection study to support assay validation testing

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

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.

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.

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