Colorectal NeoplasmsNCT01793207
Peripheral Blood DNA Methylation Markers for the Early Detection of Colorectal Carcinoma in the Egyptian Population
An observational study of Colorectal Neoplasms and Adenoma, run by Cairo University at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Neoplasms, Adenoma, Colorectal Tumors
- How many people
- 316 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients refered to Kasr-Alaini endoscopy unit and National cancer institute endoscopy department for colonoscopy.
Who may be able to join
- Patients undergoing colonoscopy as part of their clinical care or part of screening program.
- Complete endoscopic examination (up to the caecum)
- Adequate colonic preparation
Who cannot join
- - 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)
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Kar-Alaini hospital (Cairo Univeristy hospital)
Cairo
National cancer institute
Cairo
About this study
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
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), science and technology development fund, Egypt
- Responsible party
- Principal investigator, Hany Shehab, Cairo University
- Investigators
- Hany M Shehab, MD, MRCP, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793207
- Sponsor's protocol ID
- CRCS001
- Other IDs
- 3023
- Status last verified
- May 2015
- First submitted
- 13 Feb 2013
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood DNA Methylation Markers for the Early Detection of Colorectal Carcinoma in the Egyptian Population
- ClinicalTrials.gov ID
- NCT01793207
- Acronym / sponsor ID
- CRCS001
- Conditions
- Colorectal Neoplasms, Adenoma, Colorectal Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), science and technology development fund, Egypt
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients refered to Kasr-Alaini endoscopy unit and National cancer institute endoscopy department for colonoscopy.
Key inclusion criteria (3 listed)
- Patients undergoing colonoscopy as part of their clinical care or part of screening program.
- Complete endoscopic examination (up to the caecum)
- Adequate colonic preparation
Key exclusion criteria (4 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hany M Shehab, MD, MRCP principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Adenoma, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.