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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01260168
First received: December 6, 2010
Last updated: November 13, 2013
Last verified: May 2013
  Purpose

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.


Condition
Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

Resource links provided by NLM:


Further study details as provided by Exact Sciences Corporation:

Primary Outcome Measures:
  • The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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:
  • To collect samples from patients diagnosed with colorectal cancers. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

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.


Enrollment: 435
Study Start Date: October 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260168

Locations
United States, Alabama
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
Clinical Research Associates
Huntsville, Alabama, United States, 35801
United States, Georgia
Atlanta Gastroenterology
Atlanta, Georgia, United States, 30308
United States, Illinois
Stroger Cook County
Chicago, Illinois, United States, 60612
Rush University Gastroenterologists
Chicago, Illinois, United States, 60612
Jesse Brown VA
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, United States, 61107
United States, Louisiana
Gastroenterology Associates
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Commonwealth Clinical Studies
Brockton, Massachusetts, United States, 02302
United States, New York
Long Island Gastrointestinal Group
Great Neck, New York, United States, 11023
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Asheville Gastroenterology
Asheville, North Carolina, United States, 28801
Southern Gastroenterology Associates
New Bern, North Carolina, United States, 28562
United States, Oregon
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, United States, 97208
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
United States, Texas
Digestive Health Specialists
Tyler, Texas, United States, 75701
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
Study Chair: Graham Lidgard, PhD Chief Scientific Officer
  More Information

No publications provided

Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01260168     History of Changes
Other Study ID Numbers: Exact Sciences 2010-A
Study First Received: December 6, 2010
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Exact Sciences Corporation:
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

Additional relevant MeSH terms:
Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on September 14, 2014