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

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).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2024

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.

Arms, Groups and Cohorts

  • Confirmed CRC with Residual Lesion
    • A diagnosis of CRC 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.

Clinical Trial Outcome Measures

Primary Measures

  • Stool-based biomarkers associated with genetic and epigenetic alterations
    • Time Frame: 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
    • The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects with confirmed colorectal cancer at the pre-intervention stage.
  • Blood-based biomarkers associated with genetic and epigenetic alterations
    • Time Frame: Point in time blood collection (1 day) at enrollment
    • The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with confirmed colorectal cancer at the pre-intervention stage.

Participating in This Clinical Trial

Inclusion Criteria

1. Participant is 40 years of age or older. 2. 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. 3. 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. 4. 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:

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/or stool specimen collection. 3. IV contrast (e.g., CT or MRI) within 1 day [or 24 hours] before blood and/or stool collection. 4. Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Exact Sciences Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Amber Cheng, 608.982.1588, acheng@exactsciences.com

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