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

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: Recruiting
• Conditions: Colorectal Cancer

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: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Amber Cheng; Phone Number: 608.982.1588; Email: acheng@exactsciences.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Completed
      • University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Completed
      • Mayo Clinic - Arizona
  • California
    • Canoga Park, California, United States, 91304
      • Recruiting
      • Alliance Research Institute
      • Principal Investigator: John Kasher
      • Contact: Omo Imaku; Phone Number: 951-283-3402; Email: omoimaku@allianceri.org
    • Chula Vista, California, United States, 91910
      • Recruiting
      • GW Research Inc
      • Principal Investigator: Gregory Wiener
      • Contact: Alejandra Carpio
    • Laguna Hills, California, United States, 92653
      • Completed
      • Tilda Research
    • San Diego, California, United States, 92103
      • Completed
      • Clinical Trials Network
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Completed
      • Gastroenterology Associates of Fairfield County, P.C.
    • Hartford, Connecticut, United States, 06016
      • Recruiting
      • Connecticut Clinical Research Institute
      • Principal Investigator: Salam Zakko
      • Contact: Cecile Guttermuth; Phone Number: 860-585-3838; Email: cguttermuth@connecticutgi.org
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University
      • Contact: Grace Cortezzo
      • Principal Investigator: Xavier Llor, Md
  • Florida
    • Tampa, Florida, United States, 33614
      • Terminated
      • Guardian Angel Research Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Christiana Ansong
      • Principal Investigator: Atsushi Sakuraba
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • DM Clinical Research/Southwest Gastroenterology
      • Principal Investigator: Charles Berkelhammer, MD
      • Contact: Ranjit Singh; Phone Number: 281-517-0550; Email: ranjit@dmclinicalresearch.com
    • Springfield, Illinois, United States, 62702
      • Recruiting
      • Southern Illinois University School of Medicine
      • Contact: Kathy Robinson
      • Principal Investigator: Venkateswara Poola
    • Urbana, Illinois, United States, 61801
      • Completed
      • Carle Foundation Hospital dba Carle Cancer Center
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Withdrawn
      • Deaconess Clinic, Inc
    • Evansville, Indiana, United States, 47713
      • Completed
      • Deaconess Clinic, Inc.
    • South Bend, Indiana, United States, 46635
      • Completed
      • Digestive Research Alliance of Michiana, LLC
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Completed
      • MZS Research, LLC
    • Monroe, Louisiana, United States, 71201
      • Completed
      • Delta Research Partners
    • Shreveport, Louisiana, United States, 71105
      • Recruiting
      • Louisiana Research Center, LLC
      • Contact: Beverly Carroll; Phone Number: 318-525-3227
      • Principal Investigator: Humberto I Aguilar, MD
    • West Monroe, Louisiana, United States, 71291
      • Completed
      • Clinical Trials of America, LLC
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Terminated
      • Capitol Research
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Withdrawn
      • Commonwealth Clinical Studies
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • Withdrawn
      • Clinical Trials Network
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55425
      • Completed
      • HealthPartners Institute
    • Saint Louis Park, Minnesota, United States, 55426
      • Completed
      • Park Nicollet Oncology Research
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Completed
      • Virtua Health Inc
  • New York
    • Binghamton, New York, United States, 13903
      • Recruiting
      • University Health Service Hospitals, Inc.
      • Contact: Kathy Hughes; Phone Number: 607-763-5368
      • Principal Investigator: Leslie Bank, MD
    • New Hyde Park, New York, United States, 11040
      • Withdrawn
      • Digestive Disease Care, PC
    • New York, New York, United States, 10003
      • Completed
      • Icahn School of Medicine at Mount Sinai Beth Israel
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Completed
      • Digestive Health Partners, PA
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Charlotte Gastroenterology & Hepatology, PLLC
      • Contact: Beth Martinotti, CCRC; Phone Number: 704-602-6564; Email: beth.martinotti@charlottegastro.com
      • Principal Investigator: Jason Wilson, MD
    • Mount Airy, North Carolina, United States, 27030
      • Withdrawn
      • Clinical Trials of America, LLC
    • Wilmington, North Carolina, United States, 28403
      • Completed
      • Trial Management Associates, LLC
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Completed
      • Clinical Trials Network
    • Mentor, Ohio, United States, 44060
      • Recruiting
      • Clinical Trials Network
      • Principal Investigator: Don Brinberg, MD
      • Contact: TJ Lockhart; Phone Number: 212 440-205-1225; Email: tlockhart@glmrx.com
    • Westlake, Ohio, United States, 44145
      • Withdrawn
      • Clinical Trials Network
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Recruiting
      • Susquehanna Research Group
      • Contact: Jessica Balay; Phone Number: 717-914-7770; Email: jbalay@gicare.com
      • Principal Investigator: Adnan Ahmad
    • Erie, Pennsylvania, United States, 16506
      • Withdrawn
      • Presque Isle Colon and Rectal Surgery, an affiliate of The Clinical Trials Network, LLC
    • Uniontown, Pennsylvania, United States, 15401
      • Recruiting
      • Frontier Clinical Research, LLC
      • Principal Investigator: Frederick Ruthardt
      • Contact: Valerie Fornili; Phone Number: 608-848-8900; Email: vfornili@frontierclinical.com
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Regional Health Services District, Inc
      • Principal Investigator: Vikas Dembla
      • Contact: Tom Leuck; Email: tleuck@gibbscc.org
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Withdrawn
      • Gastro One
    • Hermitage, Tennessee, United States, 37076
      • Completed
      • Digestive Health Research, LLC
    • Jackson, Tennessee, United States, 38305
      • Completed
      • The Jackson Clinic Professional Association
    • Union City, Tennessee, United States, 38261
      • Recruiting
      • Advanced Gastroenterology
      • Principal Investigator: Kofi Nuako, MD
      • Contact: LaMonica Connell
  • Texas
    • Cypress, Texas, United States, 77429
      • Completed
      • Northside Gastroenterology Associates PA
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Ilimbek Beketaev Beketaev; Phone Number: 713-500-5232; Email: Ilimbek.Beketaev@uth.tmc.edu
      • Principal Investigator: Tanima Jana
    • Houston, Texas, United States, 77024
      • Completed
      • Digestive Health
    • Texarkana, Texas, United States, 75503
      • Completed
      • Texarkana Clinical Research
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Recruiting
      • Blue Ridge Medical Research
      • Contact: Heather Wilson; Phone Number: 434-455-8659; Email: heather.wilson@gastrocentralva.com
      • Principal Investigator: Larry E Clark Jr., MD
    • Suffolk, Virginia, United States, 23434
      • Recruiting
      • Virginia Gastroenterology Institute
      • Contact: Wendy Crawford; Phone Number: 757-942-2566; Email: wcrawford@virginiagastro.com
      • Principal Investigator: Pramod Malik, MD
  • Washington
    • Tacoma, Washington, United States, 98405
      • Completed
      • MultiCare Institute for Research & Innovation - Tacoma
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Completed
      • HSHS St. Vincent Hospital Regional Cancer Center

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Sample Collection; Stool DNA; Blood Draw
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID 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