Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

Clalit Health Services

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: blood-sample based diagnostic assay

Study type: Observational

Funder types: Other

Identifiers

NCT01214512

MMC10097/2010k-CTIL

Details and patient eligibility

About

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 peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and cancer).

Enrollment: 229 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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