Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

March 10, 2013 updated by: Meir Medical Center

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

229

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Colonoscopy and CD24 assay correlation
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • MMC10097/2010k-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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