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

Completed

• Conditions: Colo-rectal Cancer; Colorectal Cancer; Cancer

• 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

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)

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

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

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

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

Easter Ct Hematology; 🇺🇸 Norwich, Connecticut, 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

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

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

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