Clinical Trials Directory

Trials / Completed

CompletedNCT03789162

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

Status
Completed
Phase
Study type
Observational
Enrollment
850 (actual)
Sponsor
Exact Sciences Corporation · Industry
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

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).

Detailed description

Participants will be 40 years of age or older, with 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 computed tomography (CT) colonography. Approximately 1500 participants will be enrolled.

Conditions

Timeline

Start date
2018-12-20
Primary completion
2025-03-31
Completion
2025-05-29
First posted
2018-12-28
Last updated
2025-06-29

Locations

45 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT03789162. Inclusion in this directory is not an endorsement.