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

Study Overview
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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.

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

Conditions
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Colorectal Cancer, Colo-rectal Cancer, Cancer

Intervention / Treatment
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* Other: Stool Sample Collection


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Lung<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Colorectal<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Prostate<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Bladder<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Uterine<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Kidney/Renal Pelvis<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Ovarian<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Liver<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Pancreas<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Stomach<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|
| Esophageal<br>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<br>* Subjects participating in the study will provide a stool sample within 30 days of enrollment.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Cologuard, Sample Collection