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

Last updated: April 22, 2025
Sponsor: Exact Sciences Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Colorectal Cancer

Rectal Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT03789162
2018-07
  • Ages > 40
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 ora colorectal lesion at least 1 cm in size suspicious for adenoma (including sessileserrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or CTcolonography.

  3. Postcolonoscopy, the residual lesion in the colon must be at least 1 cm in size asto require additional surgical excision or complex colonoscopic polypectomy.

  4. Participant understands the study procedures and is able to provide informed consentto take part in the study and authorization for release of relevant protected healthinformation to the study Investigator.

Exclusion

Exclusion Criteria:

  1. Any previous cancer diagnosis (with the exceptions of basal cell or squamous cellskin 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 stoolcollection.

  4. Participant has any condition that in the opinion of the Investigator shouldpreclude taking part in the study.

Study Design

Total Participants: 1500
Study Start date:
December 20, 2018
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre

    Calgary, Alberta T2N 1N4
    Canada

    Site Not Available

  • Mayo Clinic - Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Alliance Research Institute

    Canoga Park, California 91304
    United States

    Site Not Available

  • GW Research Inc

    Chula Vista, California 91910
    United States

    Site Not Available

  • Alliance Research Center

    Laguna Hills, California 92653
    United States

    Completed

  • Tilda Research

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Clinical Trials Network

    San Diego, California 92103
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    San Diego, California 92103
    United States

    Completed

  • Gastroenterology Associates of Fairfield County, P.C.

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Connecticut Clinical Research Institute

    Hartford, Connecticut 06016
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Guardian Angel Research Center

    Tampa, Florida 33614
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • DM Clinical Research/Southwest Gastroenterology

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Carle Foundation Hospital dba Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Deaconess Clinic, Inc

    Evansville, Indiana 47713
    United States

    Site Not Available

  • Deaconess Clinic, Inc.

    Evansville, Indiana 47713
    United States

    Site Not Available

  • Digestive Research Alliance of Michiana, LLC

    South Bend, Indiana 46635
    United States

    Site Not Available

  • MZS Research, LLC

    Metairie, Louisiana 70001
    United States

    Site Not Available

  • Delta Research Partners

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    West Monroe, Louisiana 71291
    United States

    Site Not Available

  • Capitol Research

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Commonwealth Clinical Studies

    Brockton, Massachusetts 02302
    United States

    Site Not Available

  • Clinical Trials Network

    East Lansing, Michigan 48823
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    East Lansing, Michigan 48823
    United States

    Site Not Available

  • HealthPartners Institute

    Saint Louis Park, Minnesota 55425
    United States

    Site Not Available

  • Park Nicollet Oncology Research

    Saint Louis Park, Minnesota 55426
    United States

    Site Not Available

  • Park Nicollet Oncology Research

    St. Louis Park, Minnesota 55426
    United States

    Site Not Available

  • Virtua Health Inc

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • University Health Service Hospitals, Inc.

    Binghamtom, New York 13903
    United States

    Site Not Available

  • University Health Service Hospitals, Inc.

    Binghamton, New York 13903
    United States

    Site Not Available

  • Digestive Disease Care, PC

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai Beth Israel

    New York, New York 10003
    United States

    Site Not Available

  • Digestive Health Partners, PA

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    Mount Airy, North Carolina 27030
    United States

    Site Not Available

  • Trial Management Associates, LLC

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Clinical Trials Network

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    Beachwood, Ohio 44122
    United States

    Completed

  • Clinical Trials Network

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Active - Recruiting

  • Clinical Trials Network

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Susquehanna Research Group

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Presque Isle Colon and Rectal Surgery, an affiliate of The Clinical Trials Network, LLC

    Erie, Pennsylvania 16506
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Spartanburg Regional Health Services District, Inc

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Digestive Health Research, LLC

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • The Jackson Clinic Professional Association

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Advanced Gastroenterology

    Union City, Tennessee 38261
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    Union City, Tennessee 38261
    United States

    Active - Recruiting

  • Northside Gastroenterology Associates PA

    Cypress, Texas 77429
    United States

    Site Not Available

  • Digestive Health

    Houston, Texas 77024
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Texarkana Clinical Research

    Texarkana, Texas 75503
    United States

    Site Not Available

  • Blue Ridge Medical Research

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Virginia Gastroenterology Institute

    Suffolk, Virginia 23434
    United States

    Site Not Available

  • MultiCare Institute for Research & Innovation - Tacoma

    Tacoma, Washington 98405
    United States

    Site Not Available

  • HSHS St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

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