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


N/A
50 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Ecologic or Community, Time Perspective: Prospective

Outcome Measure:

Colonoscopy and CD24 assay correlation

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

Israel: Clalit Health Services

Study ID:

MMC10097/2010k-CTIL

NCT ID:

NCT01214512

Start Date:

January 2011

Completion Date:

August 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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