Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
1 other identifier
observational
435
2 countries
21
Brief Summary
The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer. Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.
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 2010
Typical duration for all trials
21 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, 2010
CompletedFirst Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 13, 2015
May 1, 2015
3.1 years
December 6, 2010
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.
12 Months
Secondary Outcomes (1)
To collect samples from patients diagnosed with colorectal cancers.
12 Months
Study Arms (1)
Colorectal cancer patients
Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or an intact pre-malignant colorectal lesion large enough to require surgical excision or complex colonoscopic polypectomy.
Eligibility Criteria
Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.
You may qualify if:
- 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 and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
- Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
You may not qualify if:
- Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
- Subject has a history of any inflammatory bowel disease.
- Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Atlanta Gastroenterology
Atlanta, Georgia, 30308, United States
Jesse Brown VA
Chicago, Illinois, 60612, United States
Rush University Gastroenterologists
Chicago, Illinois, 60612, United States
Stroger Cook County
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, 61107, United States
Gastroenterology Associates
Baton Rouge, Louisiana, 70809, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
Long Island Gastrointestinal Group
Great Neck, New York, 11023, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Asheville Gastroenterology
Asheville, North Carolina, 28801, United States
Southern Gastroenterology Associates
New Bern, North Carolina, 28562, United States
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, 97208, United States
Gastro One
Germantown, Tennessee, 38138, United States
Digestive Health Specialists
Tyler, Texas, 75701, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
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
Residual specimens and histopathology tissue slides or blocks will be stored for up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the Sponsor.
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
December 6, 2010
First Posted
December 15, 2010
Study Start
October 1, 2010
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
May 13, 2015
Record last verified: 2015-05