Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

Performance Evaluation of the Micromedic CD24 Western Blot and ELISA in Vitro Diagnostic Assay

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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: blood-sample based diagnostic assay

• Study Type: Observational
• Enrollment (Actual): 229

Contacts and Locations

Study Locations

• Israel
  • Bat Yam, Israel
    • Bat Yamon Gastroentrology Clinic
  • Tel Aviv, Israel
    • Zamenhoff Gastroentrology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects aged 50 years and above that are referred to colonoscopy assessment

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colonoscopy and CD24 assay correlation	12 months

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: October 3, 2010
• First Posted (Estimate): October 5, 2010

Study Record Updates

• Last Update Posted (Estimate): March 12, 2013
• Last Update Submitted That Met QC Criteria: March 10, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MMC10097/2010k-CTIL