Stool Collection Sub-Study of Exact Sciences Protocol 2018-01
Status
Completed
Conditions
Colo-rectal Cancer
Cancer
Colorectal Cancer
Treatments
Other: Stool Sample Collection
Details and patient eligibility
About
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.
Enrollment
291 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
291 participants in 12 patient groups
Breast
Description:
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.
Treatment:
Other: Stool Sample Collection
Lung
Description:
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.
Treatment:
Other: Stool Sample Collection
Colorectal
Description:
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.
Treatment:
Other: Stool Sample Collection
Prostate
Description:
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.
Treatment:
Other: Stool Sample Collection
Bladder
Description:
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.
Treatment:
Other: Stool Sample Collection
Uterine
Description:
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.
Treatment:
Other: Stool Sample Collection
Kidney/Renal Pelvis
Description:
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.
Treatment:
Other: Stool Sample Collection
Ovarian
Description:
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.
Treatment:
Other: Stool Sample Collection
Liver
Description:
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.
Treatment:
Other: Stool Sample Collection
Pancreas
Description:
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.
Treatment:
Other: Stool Sample Collection
Stomach
Description:
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.
Treatment:
Other: Stool Sample Collection
Esophageal
Description:
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.
Treatment:
Other: Stool Sample Collection
Trial contacts and locations
12
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Data sourced from clinicaltrials.gov
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