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Peripheral Blood DNA Methylation Markers for the Early Detection of Colorectal Carcinoma in the Egyptian Population

NCT01793207 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 316

Last updated 2015-05-06

No results posted yet for this study

Summary

The incidence of colorectal cancer (CRC) is on the rise on a global scale. The number of cancer-related deaths related to CRC is also rising to an alarming level. This picture is similarly seen in Egypt where the incidence of colorectal carcinoma is increasing annually, moreover, CRC in Egypt exhibits an alarming characteristic which is the affection of much younger patients than their counterparts worldwide. Fortunately, the early detection of CRC and its precursor (adenoma) has been shown to markedly decrease morbidity and mortality related to this tumor, this has prompted the development of robust screening programs for CRC in several western countries. The implementation of a CRC screening program in Egypt has been hampered by the low compliance of the patients and the relatively high cost of colonoscopy. There is a need for an affordable, non-invasive, simple, accurate and socially accepted screening test to allow such a program to succeed in Egypt. Recent studies have shown that DNA is the future target of screening tests for several malignancies. Particularly for CRC a few preliminary studies have shown encouraging results with separate DNA methylation markers both in blood and stool. In our efforts to develop a screening test with the criteria stated above, the investigators have decided to join the forces of 2 of the largest medical centers in Egypt and the middle-east: Kasr-Alaini hospital and the National cancer institute (NCI). The investigators plan to test a panel of 7 DNA methylation markers in peripheral blood for their performance as an early marker for CRC and colorectal adenomas. Data from this study will pave the way for the development of a screening test for CRC "tailored" to the Egyptian population, moreover, it will supply essential data about the genetic alterations occurring in CRC in Egyptian patients.

Conditions

  • Colorectal Neoplasms
  • Adenoma
  • Colorectal Tumors

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • science and technology development fund, Egypt

    collaborator UNKNOWN

  • Cairo University

    lead OTHER

Principal Investigators

  • Hany M Shehab, MD, MRCP · Cairo University

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01793207 on ClinicalTrials.gov