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

NCT ID: NCT04473625

Last Updated: 2022-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-21

Study Completion Date

2022-05-25

Brief Summary

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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

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Conditions

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Colorectal Cancer Colo-rectal Cancer Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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.

Stool Sample Collection

Intervention Type OTHER

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

Interventions

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Stool Sample Collection

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exact Sciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Clinical Research Center, Inc.

Tucson, Arizona, United States

Site Status

Genesis Cancer Center

Hot Springs, Arkansas, United States

Site Status

CARTI Cancer Center

Little Rock, Arkansas, United States

Site Status

Marin Cancer Care

Greenbrae, California, United States

Site Status

Easter Ct Hematology

Norwich, Connecticut, United States

Site Status

CSNF- Central Business Office

Jacksonville, Florida, United States

Site Status

Park Nicollet Institute - Oncology Research

Saint Louis Park, Minnesota, United States

Site Status

St. Dominic's Gynecologic Oncology

Jackson, Mississippi, United States

Site Status

Cone Health Cancer Center

Greensboro, North Carolina, United States

Site Status

The Jackson Clinic

Jackson, Tennessee, United States

Site Status

Community Cancer Trials of Utah

Ogden, Utah, United States

Site Status

CAMC Clinical Trials Center

Charleston, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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2018-01B

Identifier Type: -

Identifier Source: org_study_id

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