Clincosm LogoSign in Get a demo

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

Sponsor
Exact Sciences Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03789162
Collaborator
(none)
750
Enrollment
47
Locations
47.4
Anticipated Duration (Months)
16
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Subjects will be men and women, 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
    Actual Study Start Date :
    Dec 20, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject is male or female, 40 years of age or older.

    2. Subject 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.

    3. Post-colonoscopy, 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. Subject understands the study procedures and is able to provide informed consent to participate 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 stool sample collection.

    3. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood and/or stool collection.

    4. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic - Arizona Phoenix Arizona United States 85054
    2 Alliance Research Institute Canoga Park California United States 91304
    3 Alliance Research Center Laguna Hills California United States 92653
    4 Great Lakes Medical Research, LLC San Diego California United States 92103
    5 Gastroenterology Associates of Fairfield County, P.C. Fairfield Connecticut United States 06824
    6 Connecticut Clinical Research Institute Hartford Connecticut United States 06016
    7 Yale University New Haven Connecticut United States 06520
    8 Guardian Angel Research Center Tampa Florida United States 33614
    9 DM Clinical Research/Southwest Gastroenterology Oak Lawn Illinois United States 60453
    10 Carle Foundation Hospital dba Carle Cancer Center Urbana Illinois United States 61801
    11 Deaconess Clinic, Inc. Evansville Indiana United States 47713
    12 Deaconess Clinic, Inc Evansville Indiana United States 47713
    13 MZS Research, LLC Metairie Louisiana United States 70001
    14 Delta Research Partners Monroe Louisiana United States 71201
    15 Louisiana Research Center, LLC Shreveport Louisiana United States 71105
    16 Clinical Trials of America, LLC West Monroe Louisiana United States 71291
    17 Capitol Research Rockville Maryland United States 20850
    18 Commonwealth Clinical Studies Brockton Massachusetts United States 02302
    19 Great Lakes Medical Research, LLC East Lansing Michigan United States 48823
    20 HealthPartners Institute Saint Louis Park Minnesota United States 55425
    21 Park Nicollet Oncology Research Saint Louis Park Minnesota United States 55426
    22 Park Nicollet Oncology Research Saint Louis Park Minnesota United States 55426
    23 Virtua Health Inc Marlton New Jersey United States 08053
    24 University Health Service Hospitals, Inc. Binghamton New York United States 13903
    25 Digestive Disease Care, PC New Hyde Park New York United States 11040
    26 Icahn School of Medicine at Mount Sinai Beth Israel New York New York United States 10003
    27 Digestive Health Partners, PA Asheville North Carolina United States 28801
    28 Charlotte Gastroenterology & Hepatology, PLLC Charlotte North Carolina United States 28207
    29 Clinical Trials of America, LLC Mount Airy North Carolina United States 27030
    30 Trial Management Associates, LLC Wilmington North Carolina United States 28403
    31 Great Lakes Medical Research, LLC Beachwood Ohio United States 44122
    32 Great Lakes Gastroenterology Research, LLC Mentor Ohio United States 44060
    33 Great Lakes Medical Research, LLC Westlake Ohio United States 44145
    34 Susquehanna Research Group Camp Hill Pennsylvania United States 17011
    35 Presque Isle Colon and Rectal Surgery, an affiliate of The Clinical Trials Network, LLC Erie Pennsylvania United States 16506
    36 Frontier Clinical Research, LLC Uniontown Pennsylvania United States 15401
    37 Gastro One Germantown Tennessee United States 38138
    38 The Jackson Clinic Professional Association Jackson Tennessee United States 38305
    39 Great Lakes Medical Research, LLC Union City Tennessee United States 38261
    40 Northside Gastroenterology Associates PA Cypress Texas United States 77429
    41 Digestive Health Houston Texas United States 77024
    42 The University of Texas Health Science Center at Houston Houston Texas United States 77030
    43 Texarkana Clinical Research Texarkana Texas United States 75503
    44 Blue Ridge Medical Research Lynchburg Virginia United States 24502
    45 Virginia Gastroenterology Institute Suffolk Virginia United States 23434
    46 HSHS St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54301
    47 University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre Calgary Alberta Canada T2N 1N4

    Sponsors and Collaborators

    • Exact Sciences Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Exact Sciences Corporation
    ClinicalTrials.gov Identifier:
    NCT03789162
    Other Study ID Numbers:
    • 2018-07
    First Posted:
    Dec 28, 2018
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Exact Sciences Corporation
    Blood Draw
    Sample Collection
    Stool DNA
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jul 27, 2022