Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast

June 25, 2025 updated by: Exact Sciences Corporation
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - Arizona
    • California
      • Canoga Park, California, United States, 91304
        • Alliance Research Institute
      • Chula Vista, California, United States, 91910
        • GW Research Inc
      • Laguna Hills, California, United States, 92653
        • Tilda Research
      • San Diego, California, United States, 92103
        • Clinical Trials Network
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Gastroenterology Associates of Fairfield County, P.C.
      • Hartford, Connecticut, United States, 06016
        • Connecticut Clinical Research Institute
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Florida
      • Tampa, Florida, United States, 33614
        • Guardian Angel Research Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • DM Clinical Research/Southwest Gastroenterology
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital dba Carle Cancer Center
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic, Inc.
      • South Bend, Indiana, United States, 46635
        • Digestive Research Alliance of Michiana, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • MZS Research, LLC
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
      • West Monroe, Louisiana, United States, 71291
        • Clinical Trials of America, LLC
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Capitol Research
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55425
        • HealthPartners Institute
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Oncology Research
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Virtua Health Inc
    • New York
      • Binghamton, New York, United States, 13903
        • University Health Service Hospitals, Inc.
      • New York, New York, United States, 10003
        • Icahn School of Medicine at Mount Sinai Beth Israel
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Digestive Health Partners, PA
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates, LLC
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Clinical Trials Network
      • Mentor, Ohio, United States, 44060
        • Clinical Trials Network
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Susquehanna Research Group
      • Uniontown, Pennsylvania, United States, 15401
        • Frontier Clinical Research, LLC
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Health Services District, Inc
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
        • Digestive Health Research, LLC
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic Professional Association
      • Union City, Tennessee, United States, 38261
        • Advanced Gastroenterology
    • Texas
      • Cypress, Texas, United States, 77429
        • Northside Gastroenterology Associates PA
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77024
        • Digestive Health
      • Texarkana, Texas, United States, 75503
        • Texarkana Clinical Research
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Research
      • Suffolk, Virginia, United States, 23434
        • Virginia Gastroenterology Institute
    • Washington
      • Tacoma, Washington, United States, 98405
        • MultiCare Institute for Research & Innovation - Tacoma
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • HSHS St. Vincent Hospital Regional Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. Participant is 40 years of age or older.
  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:

  1. 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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stool-based biomarkers associated with genetic and epigenetic alterations
Time Frame: 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.
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
Time Frame: 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.
Point in time blood collection (1 day) at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Exact Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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