Stool Collection Sub-Study of Exact Sciences Protocol 2018-01

Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: "Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

The primary objective of this sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer.

Study Overview

• Status: Completed
• Conditions: Cancer; Colorectal Cancer; Colo-rectal Cancer
• Intervention / Treatment: Other: Stool Sample Collection

• Study Type: Observational
• Enrollment (Actual): 291

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Arizona Clinical Research Center, Inc.
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
    • Little Rock, Arkansas, United States, 72205
      • CARTI Cancer Center
  • California
    • Greenbrae, California, United States, 94904
      • Marin Cancer Care
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Easter Ct Hematology
  • Florida
    • Jacksonville, Florida, United States, 32256
      • CSNF- Central Business Office
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Institute - Oncology Research
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • St. Dominic's Gynecologic Oncology
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • Cone Health Cancer Center
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • The Jackson Clinic
  • Utah
    • Ogden, Utah, United States, 84405
      • Community Cancer Trials of Utah
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be men and women, 18 years of age or older, who enroll in Exact Sciences Protocol 2018-01. Approximately 450 subjects will be enrolled.

Description

Inclusion Criteria:

• Subject is currently enrolled in Exact Sciences Protocol 2018-01.
• Subject is willing and able to provide a stool sample.
• Subject understands the study procedures and is able to provide written informed consent to participate in the study.

Exclusion Criteria:

• Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the sub-study protocol, or put the person at undue risk.

Study Plan

How is the study designed?

Number of groups / cohorts

12

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast; Subjects with clinically confirmed breast cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Lung; Subjects with clinically confirmed lung cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Colorectal; Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Prostate; Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Bladder; Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Uterine; Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Kidney/Renal Pelvis; Subjects with clinically confirmed or suspicion of kidney/renal pelvis cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Ovarian; Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Liver; Subjects with clinically confirmed liver cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Pancreas; Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Stomach; Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Esophageal; Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur.	Other: Stool Sample Collection; Subjects participating in the study will provide a stool sample within 30 days of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool-based test for colorectal cancer	Research for the development and validation of a stool-based test for colorectal cancer	Point in time (one day) stool collection within 30 days of enrollment

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Sample Collection; Cologuard
• 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: 2018-01B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.
• IPD Sharing Time Frame: Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
• IPD Sharing Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No