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NCT03789162Completed

Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast

Source: ClinicalTrials.gov · Last updated 29 Jun 2025

Brief summary (registry, in English)

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC).

Status (registry)
Completed
Study type
Observational
Enrollment
850 (actual)
First submitted
18 Dec 2018
Start date
20 Dec 2018
Primary completion date
31 Mar 2025
Lead sponsor
Exact Sciences Corporation
NCT number
NCT03789162

What you commit to

  • Study type: Observational
  • Participants enrolled: 850
  • From 20 Dec 2018 to the primary completion date, 31 Mar 2025
  • 45 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g., chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
  • Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.

Other

  • Less than 7 days between colonoscopy and blood and/or stool specimen collection.
  • IV contrast (e.g., CT or MRI) within 1 day \[or 24 hours\] before blood and/or stool collection.

Who the study is looking for

  • Participant is 40 years of age or older.
  • Participant has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or CT colonography.
  • Postcolonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
  • Participant understands the study procedures and is able to provide informed consent to take part in the study and authorization for release of relevant protected health information to the study Investigator.

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (45)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Digestive Health Partners, PA
Coordinator of this site? Confirm its status
AshevilleUnited StatesUnknown status
Clinical Trials Network
Coordinator of this site? Confirm its status
BeachwoodUnited StatesUnknown status
University Health Service Hospitals, Inc.
Coordinator of this site? Confirm its status
BinghamtonUnited StatesUnknown status
Susquehanna Research Group
Coordinator of this site? Confirm its status
Camp HillUnited StatesUnknown status
Alliance Research Institute
Coordinator of this site? Confirm its status
Canoga ParkUnited StatesUnknown status
Charlotte Gastroenterology & Hepatology, PLLC
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
GW Research Inc
Coordinator of this site? Confirm its status
Chula VistaUnited StatesUnknown status
Northside Gastroenterology Associates PA
Coordinator of this site? Confirm its status
CypressUnited StatesUnknown status
Deaconess Clinic, Inc.
Coordinator of this site? Confirm its status
EvansvilleUnited StatesUnknown status
Gastroenterology Associates of Fairfield County, P.C.
Coordinator of this site? Confirm its status
FairfieldUnited StatesUnknown status
HSHS St. Vincent Hospital Regional Cancer Center
Coordinator of this site? Confirm its status
Green BayUnited StatesUnknown status
Connecticut Clinical Research Institute
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HartfordUnited StatesUnknown status
Digestive Health Research, LLC
Coordinator of this site? Confirm its status
HermitageUnited StatesUnknown status
Digestive Health
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
The University of Texas Health Science Center at Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
The Jackson Clinic Professional Association
Coordinator of this site? Confirm its status
JacksonUnited StatesUnknown status
Tilda Research
Coordinator of this site? Confirm its status
Laguna HillsUnited StatesUnknown status
Blue Ridge Medical Research
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LynchburgUnited StatesUnknown status
Virtua Health Inc
Coordinator of this site? Confirm its status
MarltonUnited StatesUnknown status
Clinical Trials Network
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MentorUnited StatesUnknown status
MZS Research, LLC
Coordinator of this site? Confirm its status
MetairieUnited StatesUnknown status
Delta Research Partners
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MonroeUnited StatesUnknown status
Yale University
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai Beth Israel
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New YorkUnited StatesUnknown status
DM Clinical Research/Southwest Gastroenterology
Coordinator of this site? Confirm its status
Oak LawnUnited StatesUnknown status
Mayo Clinic - Arizona
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Capitol Research
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RockvilleUnited StatesUnknown status
Park Nicollet Oncology Research
Coordinator of this site? Confirm its status
Saint Louis ParkUnited StatesUnknown status
HealthPartners Institute
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Saint Louis ParkUnited StatesUnknown status
Clinical Trials Network
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San DiegoUnited StatesUnknown status
Louisiana Research Center, LLC
Coordinator of this site? Confirm its status
ShreveportUnited StatesUnknown status
Digestive Research Alliance of Michiana, LLC
Coordinator of this site? Confirm its status
South BendUnited StatesUnknown status
Spartanburg Regional Health Services District, Inc
Coordinator of this site? Confirm its status
SpartanburgUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Virginia Gastroenterology Institute
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SuffolkUnited StatesUnknown status
MultiCare Institute for Research & Innovation - Tacoma
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TacomaUnited StatesUnknown status
Guardian Angel Research Center
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TampaUnited StatesUnknown status
Texarkana Clinical Research
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TexarkanaUnited StatesUnknown status
Advanced Gastroenterology
Coordinator of this site? Confirm its status
Union CityUnited StatesUnknown status
Frontier Clinical Research, LLC
Coordinator of this site? Confirm its status
UniontownUnited StatesUnknown status
Carle Foundation Hospital DBA Carle Cancer Center
Coordinator of this site? Confirm its status
UrbanaUnited StatesUnknown status
Clinical Trials of America, LLC
Coordinator of this site? Confirm its status
West MonroeUnited StatesUnknown status
Trial Management Associates, LLC
Coordinator of this site? Confirm its status
WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.