Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
- Conditions
- Colorectal Cancer
- Registration Number
- NCT03789162
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC).
- Detailed Description
Participants will be 40 years of age or older, with a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or computed tomography (CT) colonography. Approximately 1500 participants will be enrolled.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Participant is 40 years of age or older.
- Participant has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or CT colonography.
- Postcolonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
- Participant understands the study procedures and is able to provide informed consent to take part in the study and authorization for release of relevant protected health information to the study Investigator.
- Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g., chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
- Less than 7 days between colonoscopy and blood and/or stool specimen collection.
- IV contrast (e.g., CT or MRI) within 1 day [or 24 hours] before blood and/or stool collection.
- Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stool-based biomarkers associated with genetic and epigenetic alterations Stool sample will be collected at least 7 days after the subject's pre-enrollment colonoscopy, but prior to initiation of bowel preparation for any follow-up procedure The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects with confirmed colorectal cancer at the pre-intervention stage.
Blood-based biomarkers associated with genetic and epigenetic alterations Point in time blood collection (1 day) at enrollment The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with confirmed colorectal cancer at the pre-intervention stage.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Tilda Research
🇺🇸Laguna Hills, California, United States
Guardian Angel Research Center
🇺🇸Tampa, Florida, United States
Mayo Clinic - Arizona
🇺🇸Phoenix, Arizona, United States
Alliance Research Institute
🇺🇸Canoga Park, California, United States
GW Research Inc
🇺🇸Chula Vista, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
DM Clinical Research/Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Clinical Trials Network
🇺🇸Mentor, Ohio, United States
Gastroenterology Associates of Fairfield County, P.C.
🇺🇸Fairfield, Connecticut, United States
Connecticut Clinical Research Institute
🇺🇸Hartford, Connecticut, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Blue Ridge Medical Research
🇺🇸Lynchburg, Virginia, United States
Texarkana Clinical Research
🇺🇸Texarkana, Texas, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Carle Foundation Hospital dba Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Deaconess Clinic, Inc.
🇺🇸Evansville, Indiana, United States
Digestive Research Alliance of Michiana, LLC
🇺🇸South Bend, Indiana, United States
MZS Research, LLC
🇺🇸Metairie, Louisiana, United States
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Clinical Trials of America, LLC
🇺🇸West Monroe, Louisiana, United States
Capitol Research
🇺🇸Rockville, Maryland, United States
HealthPartners Institute
🇺🇸Saint Louis Park, Minnesota, United States
Park Nicollet Oncology Research
🇺🇸St. Louis Park, Minnesota, United States
Virtua Health Inc
🇺🇸Marlton, New Jersey, United States
University Health Service Hospitals, Inc.
🇺🇸Binghamtom, New York, United States
Icahn School of Medicine at Mount Sinai Beth Israel
🇺🇸New York, New York, United States
Digestive Health Partners, PA
🇺🇸Asheville, North Carolina, United States
Charlotte Gastroenterology & Hepatology, PLLC
🇺🇸Charlotte, North Carolina, United States
Trial Management Associates, LLC
🇺🇸Wilmington, North Carolina, United States
Susquehanna Research Group
🇺🇸Camp Hill, Pennsylvania, United States
Frontier Clinical Research, LLC
🇺🇸Uniontown, Pennsylvania, United States
Spartanburg Regional Health Services District, Inc
🇺🇸Spartanburg, South Carolina, United States
Digestive Health Research, LLC
🇺🇸Hermitage, Tennessee, United States
The Jackson Clinic Professional Association
🇺🇸Jackson, Tennessee, United States
Advanced Gastroenterology
🇺🇸Union City, Tennessee, United States
Northside Gastroenterology Associates PA
🇺🇸Cypress, Texas, United States
Digestive Health
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Virginia Gastroenterology Institute
🇺🇸Suffolk, Virginia, United States
MultiCare Institute for Research & Innovation - Tacoma
🇺🇸Tacoma, Washington, United States
HSHS St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre
🇨🇦Calgary, Alberta, Canada