Status:
COMPLETED
Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay
Lead Sponsor:
Meir Medical Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
50+ years
Brief Summary
This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect CD24 protein in ...
Eligibility Criteria
Inclusion
- Subject is 50 years old and above
- Subject is asymptomatic and referred for regular recommended screening colonoscopy or subject is referred due to suspicion of colon cancer, prior to beginning of any treatment (enriched population)
- Subject signed the informed consent
Exclusion
- Subject has been previously diagnosed with any type of cancer
- Subject has been previously diagnosed with a colorectal abnormality such as colorectal adenoma, hyperplastic polyp or carcinoma
- Blood sample was not collected on the day of colonoscopy and prior to colonoscopy
- Subject has first degree family history of colorectal cancer
- Subject has active infection or inflammation as determined clinically at screening
- Subject is currently taking medications related to the previous exclusion criteria
- Subject has participated in, or is participating in, any investigational drug or device study within 30 days prior the date of colonoscopy and any additional study required test
- Pregnant or lactating woman
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT01214512
Start Date
January 1 2011
End Date
August 1 2012
Last Update
March 12 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Bat Yamon Gastroentrology Clinic
Bat Yam, Israel
2
Zamenhoff Gastroentrology Clinic
Tel Aviv, Israel