Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
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|ClinicalTrials.gov Identifier: NCT01260168|
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : May 13, 2015
The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer.
Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.
|Condition or disease|
|Colorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer|
|Study Type :||Observational|
|Actual Enrollment :||435 participants|
|Official Title:||Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Colorectal cancer patients
Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or an intact pre-malignant colorectal lesion large enough to require surgical excision or complex colonoscopic polypectomy.
- The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms. [ Time Frame: 12 Months ]The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.
- To collect samples from patients diagnosed with colorectal cancers. [ Time Frame: 12 Months ]Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the sponsor.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260168
|Study Chair:||Graham Lidgard, PhD||Chief Scientific Officer|