Clinical trial NCT01260168: Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Official title: Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer
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
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 435
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.

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.

Eligibility 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.

Primary outcomes:
measure: The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
timeFrame: 12 Months
Secondary outcomes:
measure: To collect samples from patients diagnosed with colorectal cancers.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Atlanta
country: United States
facility: Atlanta Gastroenterology
state: Georgia
city: Chicago
country: United States
facility: Jesse Brown VA
state: Illinois
city: Chicago
country: United States
facility: Rush University Gastroenterologists
state: Illinois
city: Chicago
country: United States
facility: Stroger Cook County
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd
state: Illinois
city: Baton Rouge
country: United States
facility: Gastroenterology Associates
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Group
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology
state: North Carolina
city: New Bern
country: United States
facility: Southern Gastroenterology Associates
state: North Carolina
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic, LLC
state: Oregon
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Tyler
country: United States
facility: Digestive Health Specialists
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: Chief Scientific Officer
name: Graham Lidgard, PhD
role: STUDY_CHAIR
References:
citation: 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.