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

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ClinicalTrials.gov Identifier: NCT04473625
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

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.

Condition or disease Intervention/treatment
Colorectal Cancer Colo-rectal Cancer Cancer Other: Stool Sample Collection

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: "Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.

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.
Other: Stool Sample Collection
Subjects participating in the study will provide a stool sample within 30 days of enrollment.




Primary Outcome Measures :
  1. Stool-based test for colorectal cancer [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Stool Collection


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473625


Contacts
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Contact: Natalie Hernandez 608-405-0389 nhernandez@exactsciences.com

Locations
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United States, Arizona
Arizona Clinical Research Center, Inc. Recruiting
Tucson, Arizona, United States, 85715
Contact: Jarrett Schonbrun       jschonbrun@acrcresearch.com   
Principal Investigator: Manuel Modiano-Revah         
United States, Arkansas
Genesis Cancer Center Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Laura Sellers    501-624-7700    lsellers@genesiscancercenter.com   
Principal Investigator: Timothy Webb         
CARTI Cancer Center Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Carla Randall    501-906-3012    crandall@carti.com   
Principal Investigator: Kamal Patel         
United States, California
Marin Cancer Care Recruiting
Greenbrae, California, United States, 94904
Contact: Jaime Chang    415-925-5000    jchang@marincancercare.com   
Principal Investigator: Jennifer Lucas         
United States, Connecticut
Easter Ct Hematology Active, not recruiting
Norwich, Connecticut, United States, 06360
United States, Florida
CSNF- Central Business Office Recruiting
Jacksonville, Florida, United States, 32256
Contact: Tiffany Dacus       Tiffany.Dacus@CSNF.us   
Principal Investigator: Miten Patel         
United States, Minnesota
Park Nicollet Institute - Oncology Research Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Justin Eklund, M.S    952-993-5710    justin.eklund@parknicollet.com   
Principal Investigator: Rachel Lerner         
United States, Mississippi
St. Dominic's Gynecologic Oncology Recruiting
Jackson, Mississippi, United States, 39216
Contact: Janet Humphreys    601-200-4479    jhumphreys@stdom.com   
Principal Investigator: Donald Paul Seago         
United States, North Carolina
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Cameo Windham, BSN, RN    336-832-0825    phnacelle.windham@conhealth.com   
Principal Investigator: Vinay K Gudena, MD         
United States, Tennessee
The Jackson Clinic Recruiting
Jackson, Tennessee, United States, 38301
Contact: Wendy Pinson       wpinson@jacksonclinic.com   
Principal Investigator: Andrew Myers         
United States, Utah
Community Cancer Trials of Utah Recruiting
Ogden, Utah, United States, 84405
Contact: Shirley Waters       admin@communitycancertrials.com   
Principal Investigator: Carl Gray         
United States, West Virginia
CAMC Clinical Trials Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Kristi Sutphin       kristi.sutphin@camc.org   
Principal Investigator: Steven Jubelirer         
Sponsors and Collaborators
Exact Sciences Corporation
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT04473625    
Other Study ID Numbers: 2018-01B
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Exact Sciences Corporation:
Colorectal Cancer
Cologuard
Sample Collection
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases