Status:
COMPLETED
Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
Lead Sponsor:
Exact Sciences Corporation
Conditions:
Colorectal Cancer
Eligibility:
All Genders
40+ years
Brief 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 f...
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 sess...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
- Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.
Key Trial Info
Start Date :
December 20 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 29 2025
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT03789162
Start Date
December 20 2018
End Date
May 29 2025
Last Update
June 29 2025
Active Locations (45)
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1
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
2
Alliance Research Institute
Canoga Park, California, United States, 91304
3
GW Research Inc
Chula Vista, California, United States, 91910
4
Tilda Research
Laguna Hills, California, United States, 92653