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

NCT ID: NCT01793207

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 316 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Colorectal Neoplasms; Adenoma; Colorectal Tumors

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal

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

No interventions assigned to this group

colorectal cancer

Patients with endoscopic and histopathological evidence of colorectal cancer

No interventions assigned to this group

Adenoma

Patients with colorectal adenomas only detected on colonoscopy

No interventions assigned to this group

Hyperplastic polyps

Patients with hyperplastic polyps detected on colonoscopy.

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

science and technology development fund, Egypt

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hany Shehab

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany M Shehab, MD, MRCP

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kar-Alaini hospital (Cairo Univeristy hospital)

Cairo, , Egypt

National cancer institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

3023

Identifier Type: OTHER

Identifier Source: secondary_id

CRCS001

Identifier Type: -

Identifier Source: org_study_id