CompletedNot Applicable

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

United States850 participantsStarted 2018-12-20

Plain-language 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).

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Stool-based biomarkers associated with genetic and epigenetic alterations

Timeframe: Stool sample will be collected at least 7 days after the subject's pre-enrollment colonoscopy, but prior to initiation of bowel preparation for any follow-up procedure

Blood-based biomarkers associated with genetic and epigenetic alterations

Timeframe: Point in time blood collection (1 day) at enrollment

Trial details

NCT IDNCT03789162

SponsorExact Sciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Colorectal Cancer trials