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CompletedNCT01793207Updated May 6, 2015

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

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

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
316
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Neoplasms
  • Adenoma
  • Colorectal Tumors
03

In context

Adenoma

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
316 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

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

    Time frame: 16 months

Secondary outcomes

  1. 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

  2. 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

07

Study locations

2 sites
  • Kar-Alaini hospital (Cairo Univeristy hospital)
    Cairo, Egypt
  • National cancer institute
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01793207
Lead sponsor
Cairo University
Collaborators
National Cancer Institute (NCI), science and technology development fund, Egypt
Responsible party
Hany Shehab (Dr., Cairo University) — Principal investigator
First posted
Feb 15, 2013
Start date
Dec 2012
Primary completion
Mar 2015
Completion
Mar 2015
Last update
May 6, 2015

Study contacts

Hany M Shehab, MD, MRCP
principal investigator · Cairo University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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