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Blood and Stool Sample Collection in Subjects with a Diagnosis of Colorectal Cancer or Colorectal Lesion 2018-07 Act Fast

  • Study HIC#:2000025393
  • Last Updated:11/16/2021

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 detection of colorectal cancer (CRC).

  • Age40 years and older
  • GenderBoth
  • Start Date07/05/2019
  • End Date12/31/2019

Trial Purpose and Description

Subjects will be men and women, 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.

Eligibility Criteria

Inclusion Criteria:

  1. Subject is male or female, 40 years of age or older.
  2. 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.
  3. 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.
  4. 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:

  1. 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.
  2. Less than 7 days between colonoscopy and blood and stool sample collection.
  3. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood and/or stool collection.
  4. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

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