Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
1 other identifier
observational
850
2 countries
45
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Longer than P75 for all trials
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2018
CompletedStudy Start
First participant enrolled
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2025
CompletedJune 29, 2025
June 1, 2025
6.3 years
December 18, 2018
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stool-based biomarkers associated with genetic and epigenetic alterations
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.
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
Blood-based biomarkers associated with genetic and epigenetic alterations
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.
Point in time blood collection (1 day) at enrollment
Study Arms (1)
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.
Eligibility Criteria
Approximately 1500 subjects will be enrolled. 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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
Alliance Research Institute
Canoga Park, California, 91304, United States
GW Research Inc
Chula Vista, California, 91910, United States
Tilda Research
Laguna Hills, California, 92653, United States
Clinical Trials Network
San Diego, California, 92103, United States
Gastroenterology Associates of Fairfield County, P.C.
Fairfield, Connecticut, 06824, United States
Connecticut Clinical Research Institute
Hartford, Connecticut, 06016, United States
Yale University
New Haven, Connecticut, 06520, United States
Guardian Angel Research Center
Tampa, Florida, 33614, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
DM Clinical Research/Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Carle Foundation Hospital dba Carle Cancer Center
Urbana, Illinois, 61801, United States
Deaconess Clinic, Inc.
Evansville, Indiana, 47713, United States
Digestive Research Alliance of Michiana, LLC
South Bend, Indiana, 46635, United States
MZS Research, LLC
Metairie, Louisiana, 70001, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Clinical Trials of America, LLC
West Monroe, Louisiana, 71291, United States
Capitol Research
Rockville, Maryland, 20850, United States
HealthPartners Institute
Saint Louis Park, Minnesota, 55425, United States
Park Nicollet Oncology Research
Saint Louis Park, Minnesota, 55426, United States
Virtua Health Inc
Marlton, New Jersey, 08053, United States
University Health Service Hospitals, Inc.
Binghamton, New York, 13903, United States
Icahn School of Medicine at Mount Sinai Beth Israel
New York, New York, 10003, United States
Digestive Health Partners, PA
Asheville, North Carolina, 28801, United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
Clinical Trials Network
Beachwood, Ohio, 44122, United States
Clinical Trials Network
Mentor, Ohio, 44060, United States
Susquehanna Research Group
Camp Hill, Pennsylvania, 17011, United States
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401, United States
Spartanburg Regional Health Services District, Inc
Spartanburg, South Carolina, 29303, United States
Digestive Health Research, LLC
Hermitage, Tennessee, 37076, United States
The Jackson Clinic Professional Association
Jackson, Tennessee, 38305, United States
Advanced Gastroenterology
Union City, Tennessee, 38261, United States
Northside Gastroenterology Associates PA
Cypress, Texas, 77429, United States
Digestive Health
Houston, Texas, 77024, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Texarkana Clinical Research
Texarkana, Texas, 75503, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434, United States
MultiCare Institute for Research & Innovation - Tacoma
Tacoma, Washington, 98405, United States
HSHS St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301, United States
University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre
Calgary, Alberta, T2N 1N4, Canada
Biospecimen
Specimens collected under this protocol may be stored indefinitely for future research in addition to and separate from the study and use of specimens and data described in the rest of this protocol. Specimens are de-identified of all protected health information and clinical study data will only be associated by a subject identification number. Specimens de-accessioned from the biorepository will be destroyed under standard biohazardous material protocol and record of the removal and destruction will be maintained for 7 years by the Sponsor. Specimens and/or data collected during this study may be used by the Sponsor and its affiliates and may also be shared with and used by other outside individuals and organizations.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2018
First Posted
December 28, 2018
Study Start
December 20, 2018
Primary Completion
March 31, 2025
Study Completion
May 29, 2025
Last Updated
June 29, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share