Cancer Clinical Trial
Official title:
Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: "Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
| NCT number | NCT04473625 |
| Other study ID # | 2018-01B |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 21, 2020 |
| Est. completion date | May 25, 2022 |
| Verified date | June 2022 |
| Source | Exact Sciences Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 291 |
| Est. completion date | May 25, 2022 |
| Est. primary completion date | March 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | CAMC Clinical Trials Center | Charleston | West Virginia |
| United States | Marin Cancer Care | Greenbrae | California |
| United States | Cone Health Cancer Center | Greensboro | North Carolina |
| United States | Genesis Cancer Center | Hot Springs | Arkansas |
| United States | St. Dominic's Gynecologic Oncology | Jackson | Mississippi |
| United States | The Jackson Clinic | Jackson | Tennessee |
| United States | CSNF- Central Business Office | Jacksonville | Florida |
| United States | CARTI Cancer Center | Little Rock | Arkansas |
| United States | Easter Ct Hematology | Norwich | Connecticut |
| United States | Community Cancer Trials of Utah | Ogden | Utah |
| United States | Park Nicollet Institute - Oncology Research | Saint Louis Park | Minnesota |
| United States | Arizona Clinical Research Center, Inc. | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Exact Sciences Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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