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

NCT01793207 | Completed

• 2 other identifiers: CRCS0013023
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (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

  16 months

Secondary Outcomes (2)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients refered to Kasr-Alaini endoscopy unit and National cancer institute endoscopy department for colonoscopy.

You may qualify if:

• Patients undergoing colonoscopy as part of their clinical care or part of screening program.
• Complete endoscopic examination (up to the caecum)
• Adequate colonic preparation

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Cairo University: lead
• National Cancer Institute (NCI): collaborator
• science and technology development fund, Egypt: collaborator

Study Sites (2)

Kar-Alaini hospital (Cairo Univeristy hospital)

Cairo, Egypt

Location

National cancer institute

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

10cc blood sample and tissue biopsies from colorectal lesions when present.

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Hany M Shehab, MD, MRCP

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

EG (2)