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Completed

NCT Number: NCT01214512

Performance Evaluation of the Micromedic CD24 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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bat Yamon Gastroentrology Clinic, Bat Yam, Israel

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood-sample based diagnostic assay

Other

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

Primary outcomes

  1. Colonoscopy and CD24 assay correlation

    Time frame: 12 months

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Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2010
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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