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Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01214512
Enrollment
229
Registered
2010-10-05
Start date
2011-01-31
Completion date
2012-08-31
Last updated
2013-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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).

Interventions

OTHERblood-sample based diagnostic assay

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

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Colonoscopy and CD24 assay correlation12 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026