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

Completed

• Conditions: Colo-rectal Cancer; Colorectal Cancer; Cancer
• Interventions: Other: Stool Sample Collection

• Registration Number: NCT04473625
• Lead Sponsor: Exact Sciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Study Start: 2020-07-21
• Primary Completion: 2022-03-31
• Study Completion: 2022-05-25
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney/Renal Pelvis	Stool Sample Collection	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.
Ovarian	Stool Sample Collection	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.
Liver	Stool Sample Collection	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.
Breast	Stool Sample Collection	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.
Stomach	Stool Sample Collection	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.
Lung	Stool Sample Collection	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.
Uterine	Stool Sample Collection	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.
Colorectal	Stool Sample Collection	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.
Prostate	Stool Sample Collection	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.
Bladder	Stool Sample Collection	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.
Pancreas	Stool Sample Collection	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.
Esophageal	Stool Sample Collection	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.

Primary Outcome Measures

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

Trial Locations

Locations (12)

Community Cancer Trials of Utah; 🇺🇸 Ogden, Utah, United States

Cone Health Cancer Center; 🇺🇸 Greensboro, North Carolina, United States

CAMC Clinical Trials Center; 🇺🇸 Charleston, West Virginia, United States

Genesis Cancer Center; 🇺🇸 Hot Springs, Arkansas, United States

CARTI Cancer Center; 🇺🇸 Little Rock, Arkansas, United States

Easter Ct Hematology; 🇺🇸 Norwich, Connecticut, United States

Arizona Clinical Research Center, Inc.; 🇺🇸 Tucson, Arizona, United States

Marin Cancer Care; 🇺🇸 Greenbrae, California, United States

CSNF- Central Business Office; 🇺🇸 Jacksonville, Florida, United States

Park Nicollet Institute - Oncology Research; 🇺🇸 Saint Louis Park, Minnesota, United States

St. Dominic's Gynecologic Oncology; 🇺🇸 Jackson, Mississippi, United States

The Jackson Clinic; 🇺🇸 Jackson, Tennessee, United States