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

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ClinicalTrials.gov Identifier: NCT01793207
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : May 6, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
science and technology development fund, Egypt
Information provided by (Responsible Party):
Hany Shehab, Cairo University

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
Colorectal Neoplasms Adenoma Colorectal Tumors

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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 : December 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Group/Cohort
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.



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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 16 months ]

Biospecimen Retention:   Samples With DNA
10cc blood sample and tissue biopsies from colorectal lesions when present.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients refered to Kasr-Alaini endoscopy unit and National cancer institute endoscopy department for colonoscopy.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793207


Locations
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Egypt
Kar-Alaini hospital (Cairo Univeristy hospital)
Cairo, Egypt
National cancer institute
Cairo, Egypt
Sponsors and Collaborators
Cairo University
National Cancer Institute (NCI)
science and technology development fund, Egypt
Investigators
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Principal Investigator: Hany M Shehab, MD, MRCP Cairo University

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Responsible Party: Hany Shehab, Dr., Cairo University
ClinicalTrials.gov Identifier: NCT01793207    
Other Study ID Numbers: CRCS001
3023 ( Other Identifier: Egyptian Science and Technological Development Fund )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases