Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
1 other identifier
observational
674
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedMay 13, 2015
May 1, 2015
10 months
May 11, 2012
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, each with a screening colonoscopy resulting in normal findings.
Eligibility Criteria
Patients are at average risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Desert Sun Clinical Research
Tucson, Arizona, 85710, United States
Remek Research
Pomona, California, 91767, United States
Sharp Rees-Stealy
San Diego, California, 92101, United States
Southern California Medical Gastroenterology Group, Inc
Santa Monica, California, 90404, United States
Miami Research Associates
Miami, Florida, 33173, United States
Atlanta Gastroenterology Associates
Marietta, Georgia, 30067, United States
Rockford Gastroenterology Associates, LTD.
Rockford, Illinois, 61107, United States
New Orleans Research Institue
Metairie, Louisiana, 70006, United States
Columbia Medical Practice
Columbia, Maryland, 21045, United States
Main Line Gastroenterology
Perkasie, Pennsylvania, 18944, United States
Professional Quality Research, Inc.
Austin, Texas, 78705, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Advanced Research Institute
Sandy City, Utah, 84094, United States
Related 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 neoplasia. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1313-8. doi: 10.1016/j.cgh.2013.04.023. Epub 2013 Apr 29.
PMID: 23639600RESULT
Biospecimen
Provide anonymous, clinically characterized specimens for bio-repository for future colorectal cancer-related test development.
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Graham Lidgard, PhD
Chief Scientific Officer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2012
First Posted
May 17, 2012
Study Start
October 1, 2011
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
May 13, 2015
Record last verified: 2015-05