- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04496765
Early-onset Rectal Cancer
July 31, 2020 updated by: Sameh Emile, Mansoura University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
244
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahlia
-
Mansourah, Dakahlia, Egypt
- Mansoura University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients of either gender aged 40 years or less who presented with rectal cancer of any stage
Description
Inclusion Criteria:
- Patients of either gender aged 40 years or less who presented with rectal cancer of any stage were included to the study
Exclusion Criteria:
- patients with colon cancer or other gastrointestinal cancer and patients who were lost to follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
< 40 years
Patients with rectal cancer ageing 40 years or less
|
Radical resection of rectal cancer and draining lymph nodes
|
> 40 years
Patients with rectal cancer ageing more than 40 years
|
Radical resection of rectal cancer and draining lymph nodes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local recurrence
Time Frame: 36 months after surgery
|
recurrence of rectal cancer within the anatomic vicinity of the pelvis
|
36 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
July 29, 2020
First Submitted That Met QC Criteria
July 31, 2020
First Posted (Actual)
August 3, 2020
Study Record Updates
Last Update Posted (Actual)
August 3, 2020
Last Update Submitted That Met QC Criteria
July 31, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mansoura2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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