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Sponsor study identifier
Secondary identifiers
OTHER · Egyptian Science and Technological Development Fund
observational
316
1 country
2
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 13, 2013
Actual (reported)February 15, 2013
Actual (reported)March 2015
Actual (reported)March 2015
Actual (reported)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
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
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
Subjects who had a normal colonoscopic examination (No polyps, masses or any evidence of colorectal neoplasia)
Patients with endoscopic and histopathological evidence of colorectal cancer
Patients with colorectal adenomas only detected on colonoscopy
Patients with hyperplastic polyps detected on colonoscopy.
Patients refered to Kasr-Alaini endoscopy unit and National cancer institute endoscopy department for colonoscopy.
Kar-Alaini hospital (Cairo Univeristy hospital)
Cairo, Egypt
National cancer institute
Cairo, Egypt
10cc blood sample and tissue biopsies from colorectal lesions when present.
Hany M Shehab, MD, MRCP
Cairo University
316 participants (actual enrollment reported by the registry).
First Submitted
February 13, 2013
First Posted
February 15, 2013
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
May 6, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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