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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT01793207
Collaborator
National Cancer Institute (NCI) (NIH), science and technology development fund, Egypt (Other)
316
Enrollment
2
Locations
26.9
Duration (Months)
158
Patients Per Site
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    316 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Peripheral Blood DNA Methylation Markers for the Early Detection of Colorectal Carcinoma in the Egyptian Population
    Study Start Date :
    Dec 1, 2012
    Actual Primary Completion Date :
    Mar 1, 2015
    Actual Study Completion Date :
    Mar 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Normal

    Subjects who had a normal colonoscopic examination (No polyps, masses or any evidence of colorectal neoplasia)
    colorectal cancer

    Patients with endoscopic and histopathological evidence of colorectal cancer
    Adenoma

    Patients with colorectal adenomas only detected on colonoscopy
    Hyperplastic polyps

    Patients with hyperplastic polyps detected on colonoscopy.

    Outcome Measures

    Primary Outcome Measures

    1. Methylation markers present in peripheral blood of patients with colorectal cancer(Sept 9, CDKN2B-p15, CDH4, SFRP2, ALX4, Neurog1 and CDH13)in comparison to their presence in other subjects [16 months]

    Secondary Outcome Measures

    1. Methylation markers present in peripheral blood of patients with colorectal adenomas (Sept 9, CDKN2B-p15, CDH4, SFRP2, ALX4, Neurog1 and CDH13)in comparison to their presence in other subjects [16 months]

    2. Methylation markers present in peripheral blood of patients with hyperplastic polyps(Sept 9, CDKN2B-p15, CDH4, SFRP2, ALX4, Neurog1 and CDH13)in comparison to their presence in other subjects [16 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing colonoscopy as part of their clinical care or part of screening program.

    • Complete endoscopic examination (up to the caecum)

    • Adequate colonic preparation

    Exclusion Criteria:
      • Incomplete colonoscopic examination due to technical causes e.g. difficult colonoscopy, patient intolerance (N.B. a neoplastic mass causing lumen stenosis will not be excluded.)

    • Poor colonic preparation obscuring adequate mucosal examination.

    • Patients who have received any treatment for CRC and/or adenomas.

    • Patients with known malignancy elsewhere (i.e. non-colorectal malignancy)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kar-Alaini hospital (Cairo Univeristy hospital) Cairo Egypt
    2 National cancer institute Cairo Egypt

    Sponsors and Collaborators

    • Cairo University
    • National Cancer Institute (NCI)
    • science and technology development fund, Egypt

    Investigators

    • Principal Investigator: Hany M Shehab, MD, MRCP, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hany Shehab, Dr., Cairo University
    ClinicalTrials.gov Identifier:
    NCT01793207
    Other Study ID Numbers:
    • CRCS001
    • 3023
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    May 6, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Adenoma
    Colorectal Neoplasms

    Study Results

    No Results Posted as of May 6, 2015