Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
NCT ID: NCT03789162
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
850 participants
OBSERVATIONAL
2018-12-20
2025-05-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
NCT03821948
Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
NCT02503631
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
NCT01260168
Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma
NCT01511653
Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
NCT01600209
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Confirmed CRC with Residual Lesion
A diagnosis of CRC 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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. 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.
4. 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.
Exclusion Criteria
2. Less than 7 days between colonoscopy and blood and/or stool specimen collection.
3. IV contrast (e.g., CT or MRI) within 1 day \[or 24 hours\] before blood and/or stool collection.
4. Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Exact Sciences Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic - Arizona
Phoenix, Arizona, United States
Alliance Research Institute
Canoga Park, California, United States
GW Research Inc
Chula Vista, California, United States
Tilda Research
Laguna Hills, California, United States
Clinical Trials Network
San Diego, California, 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
Guardian Angel Research Center
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
DM Clinical Research/Southwest Gastroenterology
Oak Lawn, Illinois, 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
Saint Louis Park, Minnesota, United States
Virtua Health Inc
Marlton, New Jersey, United States
University Health Service Hospitals, Inc.
Binghamton, 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
Clinical Trials Network
Beachwood, Ohio, United States
Clinical Trials Network
Mentor, Ohio, 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
Texarkana Clinical Research
Texarkana, Texas, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.