Rectal CancerNCT04496765
Early-onset Rectal Cancer
An observational study of Rectal Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
The present study aimed to review the characteristics and outcome of early-onset rectal cancer in a subset of Egyptian patients aged 40 years or less. Since the previous studies assessed this point of research in CRC overall, the investigators opted to focus upon rectal cancer alone since it may represent a separate… Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Total mesorectal excision
- Type of treatment
- Surgery or procedure
- How many people
- 244 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2008to 30 Apr 2020
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of either gender aged 40 years or less who presented with rectal cancer of any stage
Who may be able to join
- Patients of either gender aged 40 years or less who presented with rectal cancer of any stage were included to the study
Who cannot join
- patients with colon cancer or other gastrointestinal cancer and patients who were lost to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients With Early-Onset Rectal Cancer Aged 40 Year or Less Have Similar Oncologic Outcomes to Older Patients Despite Presenting in More Advanced Stage; A Retrospective Cohort Study
The present study aimed to review the characteristics and outcome of early-onset rectal cancer in a subset of Egyptian patients aged 40 years or less. Since the previous studies assessed this point of research in CRC overall, the investigators opted to focus upon rectal cancer alone since it may represent a separate category, distinct from colon cancer, in this age group with regards to presentation, tumor behavior, and outcome.
- Conditions
- Rectal Cancer
- Being tested
- Total mesorectal excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total mesorectal excisionProcedure or surgery
Radical resection of rectal cancer and draining lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| < 40 years | Patients with rectal cancer ageing 40 years or less Receives: Procedure: Total mesorectal excision | |
| > 40 years | Patients with rectal cancer ageing more than 40 years Receives: Procedure: Total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence
recurrence of rectal cancer within the anatomic vicinity of the pelvis
Measured: 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Jan 2008
- Primary completion1 Dec 2017
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496765
- Sponsor's protocol ID
- Mansoura2020
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Early-Onset Rectal Cancer Aged 40 Year or Less Have Similar Oncologic Outcomes to Older Patients Despite Presenting in More Advanced Stage; A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04496765
- Acronym / sponsor ID
- Mansoura2020
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 3 Aug 2020 (actual)
- 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 present study aimed to review the characteristics and outcome of early-onset rectal cancer in a subset of Egyptian patients aged 40 years or less. Since the previous studies assessed this point of research in CRC overall, the investigators opted to focus upon rectal cancer alone since it may represent a separate category, distinct from colon cancer, in this age group with regards to presentation, tumor behavior, and outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| < 40 years | – | Procedure: Total mesorectal excisionPatients with rectal cancer ageing 40 years or less |
| > 40 years | – | Procedure: Total mesorectal excisionPatients with rectal cancer ageing more than 40 years |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of either gender aged 40 years or less who presented with rectal cancer of any stage
Key inclusion criteria (1 listed)
- Patients of either gender aged 40 years or less who presented with rectal cancer of any stage were included to the study
Key exclusion criteria (1 listed)
- patients with colon cancer or other gastrointestinal cancer and patients who were lost to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total mesorectal excisionRadical resection of rectal cancer and draining lymph nodes | Procedure or surgery | < 40 years, > 40 years |
Primary outcome
Local recurrence
Time frame: 36 months after surgery
recurrence of rectal cancer within the anatomic vicinity of the pelvis
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 3 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Sameh H Emile study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Mansoura University at 1 site 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 1 inclusion and 1 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Local recurrence (time frame: 36 months after surgery). 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 3 Aug 2020.