Colorectal Cancer, Colo-rectal Cancer, Cancer
Conditions
Keywords
Colorectal Cancer, Cologuard, Sample Collection
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.
Interventions
Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Sponsors
Exact Sciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed