Stool Collection Sub-Study of Exact Sciences Protocol 2018-01
1 other identifier
observational
291
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 16, 2020
CompletedStudy Start
First participant enrolled
July 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2022
CompletedJune 6, 2022
June 1, 2022
1.7 years
July 13, 2020
June 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (12)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Subjects participating in the study will provide a stool sample within 30 days of enrollment.
Eligibility Criteria
Subjects will be men and women, 18 years of age or older, who enroll in Exact Sciences Protocol 2018-01. Approximately 450 subjects will be enrolled.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
Marin Cancer Care
Greenbrae, California, 94904, United States
Easter Ct Hematology
Norwich, Connecticut, 06360, United States
CSNF- Central Business Office
Jacksonville, Florida, 32256, United States
Park Nicollet Institute - Oncology Research
Saint Louis Park, Minnesota, 55426, United States
St. Dominic's Gynecologic Oncology
Jackson, Mississippi, 39216, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
The Jackson Clinic
Jackson, Tennessee, 38301, United States
Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
Biospecimen
Stool Collection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 16, 2020
Study Start
July 21, 2020
Primary Completion
March 31, 2022
Study Completion
May 25, 2022
Last Updated
June 6, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol and informed consent form (when applicable) will also be shared.