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

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.

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Key information

Conditions

Colorectal Cancer Cancer Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Clinical Research Center, Inc., Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool Sample Collection

Other

Subjects participating in the study will provide a stool sample within 30 days of enrollment.

Primary outcomes

Stool-based test for colorectal cancer

Time frame: 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

Sponsors and collaborators

Lead sponsor

Exact Sciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jul 16, 2020
Registry last updated: Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed