Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

Completed

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 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).

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Colonoscopy and CD24 assay correlation	12 months

Secondary Outcome Measures

Name	Time	Method

Locations (2): Bat Yamon Gastroentrology Clinic
🇮🇱
Bat Yam, Israel
Zamenhoff Gastroentrology Clinic
🇮🇱
Tel Aviv, Israel

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