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Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

NCT01397747 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12776

Last updated 2015-12-03

Study results available
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Summary

The primary objective is to determine the sensitivity and specificity of the Exact Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination.

The secondary objective is to compare the performance of the Exact CRC screening test to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Conditions

Sponsors & Collaborators

  • Exact Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • Thomas Imperiale, MD · Principal Study Investigator

Eligibility

Min Age
50 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-02-28
Completion
2013-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01397747 on ClinicalTrials.gov