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Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast (ES2018-07)

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

Overview

Overview

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).

Key Inclusion Criteria

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply

  • Subject is male or female, 40 years of age or older.
  • Subject 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.
  • Post-colonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria

Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.

  • 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 stool sample collection.
  • IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood and/or stool collection.
  • Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Learn More

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Observational

Sponsor (s)

Exact Sciences Corporation

Contact Us

Contact Us

To participate in this study please contact Tom Leuck at (864)560-1980
tleuck@gibbscc.org