An observational study in Colorectal Neoplasms, Adenoma and Colorectal Tumors, sponsored by Cairo University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-05-06.
Sponsored by Cairo University · Observational
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 316 is close to the median of 300 across 226 observational studies indexed under Adenoma.
Browse Adenoma studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients refered to Kasr-Alaini endoscopy unit and National cancer institute endoscopy department for colonoscopy.
Exclusion Criteria:
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.
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
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
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
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Cairo University