Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

NCT01214512 | Completed

• 1 other identifier: MMC10097/2010k-CTIL
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 2

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).

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Colonoscopy and CD24 assay correlation

  12 months

Interventions

blood-sample based diagnostic assay OTHER

A blood sample will be used in a Western blot and ELISA assay to determine CD24 levels

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (2)

Bat Yamon Gastroentrology Clinic

Bat Yam, Israel

Location

Zamenhoff Gastroentrology Clinic

Tel Aviv, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fresh blood samples are collected and separated. Plasma is collected and stored and rest is discarded of. Leukocytes are separated, lysed and the supernatant is stored. As DNA is retained in the pellet, which is discarded, no DNA is retained in the samples stored.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: October 5, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

IL (2)