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Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

Completed
Conditions
Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer
Registration Number
NCT01260168
Lead Sponsor
Exact Sciences Corporation
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.

Detailed Description

Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
435
Inclusion Criteria
  1. Subject is male or female, 40-90 years of age, inclusive.
  2. 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.
  3. 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.
Exclusion Criteria
  1. Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
  2. Subject has a history of any inflammatory bowel disease.
  3. Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
  4. 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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.12 Months

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.

Secondary Outcome Measures
NameTimeMethod
To collect samples from patients diagnosed with colorectal cancers.12 Months

Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the sponsor.

Trial Locations

Locations (21)

Achieve Clinical Research, LLC

🇺🇸

Birmingham, Alabama, United States

Clinical Research Associates

🇺🇸

Huntsville, Alabama, United States

Atlanta Gastroenterology

🇺🇸

Atlanta, Georgia, United States

Jesse Brown VA

🇺🇸

Chicago, Illinois, United States

Rush University Gastroenterologists

🇺🇸

Chicago, Illinois, United States

Stroger Cook County

🇺🇸

Chicago, Illinois, United States

University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

Rockford Gastroenterology Associates, Ltd

🇺🇸

Rockford, Illinois, United States

Gastroenterology Associates

🇺🇸

Baton Rouge, Louisiana, United States

Chevy Chase Clinical Research

🇺🇸

Chevy Chase, Maryland, United States

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Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States

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