Clinical trial NCT02503631: Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Official title: Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Study type: OBSERVATIONAL
Overall status: TERMINATED
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: 2015-07-21
Enrollment: 397
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.

Brief summary: The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

Detailed description: This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.

One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.

Eligibility criteria: Inclusion Criteria:

* 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 or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
* Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

* Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
* 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: To provide stool and blood specimens to assess new markers for the detection of CRC
timeFrame: 33 months
Secondary outcomes:
measure: To provide stool and blood specimens for use as controls when assessing new markers for the detection of neoplasms in other locations within the digestive tract (esophagus, stomach, pancreas, etc.)
timeFrame: 33 months
measure: To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development
timeFrame: 33 months
measure: To provide quality control material for use in assessing performance of developed assays
timeFrame: 33 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: John D. Homan, MD
state: California
city: Hamden
country: United States
facility: Medical Research Center of Connecticut
state: Connecticut
city: Holiday
country: United States
facility: Gulf Coast Research Group, LLC
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research, Inc.
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Metairie
country: United States
facility: Colon and Rectal Surgery Associates
state: Louisiana
city: Metairie
country: United States
facility: New Orleans Research Institute
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
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: Columbia
country: United States
facility: DBA Boone Hospital Center
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic, LLC
state: Oregon
city: Malvern
country: United States
facility: Main Line Gastroenterology Associates
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Lynchburg
country: United States
facility: Blue Ridge Medical Researcj
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Calgary
country: Canada
facility: Forzani & MacPhali Colon Cancer Screening Centre
state: Alberta
Study officials:
affiliation: Exact Sciences
name: Michael Domanico
role: STUDY_CHAIR
References: