Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214512
• Other study ID #: MMC10097/2010k-CTIL
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: March 10, 2013
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Other:
• blood-sample based diagnostic assay
A blood sample will be used in a Western blot and ELISA assay to determine CD24 levels

Locations

Country	Name	City	State
Israel	Bat Yamon Gastroentrology Clinic	Bat Yam
Israel	Zamenhoff Gastroentrology Clinic	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonoscopy and CD24 assay correlation		12 months	No