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NCT01397747 · ClinicalTrials.gov registry record
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
A clinical trial, sponsored by Exact Sciences Corporation.
- Completed
- Registry status
- 12,776
- Enrollment target
NCT01397747: Completed study, sponsored by Exact Sciences Corporation.
NCT01397747 is a clinical trial that has completed, run by Exact Sciences Corporation. The registered enrollment target is 12,776 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397747 has completed, sponsored by Exact Sciences Corporation.
- COMPLETED
- Registry status
- 12,776 participants
- Enrollment target
Study 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.
Primary Outcome
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,776 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-05 |
What the finished NCT01397747 record still lists
NCT01397747 is an observational study that tracks outcomes without assigning an intervention. Its 12,776 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01397747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01397747 about?
NCT01397747 is a clinical study titled "Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer". 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 th...
What is the current status of trial NCT01397747?
This trial is currently completed. The enrollment target is 12,776 participants. The study started on 2011-06. Estimated completion is 2013-05.
Who is sponsoring clinical trial NCT01397747?
This trial is sponsored by Exact Sciences Corporation, which has 30 total clinical trials registered on ClinicalTrials.gov.
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