Clinical trial NCT01793207: Peripheral Blood DNA Methylation Markers for the Early Detection of Colorectal Carcinoma in the Egyptian Population
Official title: Peripheral Blood DNA Methylation Markers for the Early Detection of Colorectal Carcinoma in the Egyptian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Adenoma
Colorectal Tumors
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: science and technology development fund, Egypt
First posted: 2013-02-15
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients refered to Kasr-Alaini endoscopy unit and National cancer institute endoscopy department for colonoscopy.

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.


Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: 16 months
Secondary outcomes:
measure: 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
timeFrame: 16 months
measure: 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
timeFrame: 16 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kar-Alaini hospital (Cairo Univeristy hospital)
city: Cairo
country: Egypt
facility: National cancer institute
Study officials:
affiliation: Cairo University
name: Hany M Shehab, MD, MRCP
role: PRINCIPAL_INVESTIGATOR
References: