NCT04496765

Brief 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 category, distinct from colon cancer, in this age group with regards to presentation, tumor behavior, and outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

9.9 years

First QC Date

July 29, 2020

Last Update Submit

July 31, 2020

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Local recurrence

    recurrence of rectal cancer within the anatomic vicinity of the pelvis

    36 months after surgery

Study Arms (2)

< 40 years

Patients with rectal cancer ageing 40 years or less

Procedure: Total mesorectal excision

> 40 years

Patients with rectal cancer ageing more than 40 years

Procedure: Total mesorectal excision

Interventions

Total mesorectal excisionPROCEDURE

Radical resection of rectal cancer and draining lymph nodes

< 40 years> 40 years

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of either gender aged 40 years or less who presented with rectal cancer of any stage

You may qualify if:

  • Patients of either gender aged 40 years or less who presented with rectal cancer of any stage were included to the study

You may not qualify if:

  • patients with colon cancer or other gastrointestinal cancer and patients who were lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Sameh H Emile

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of surgery

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 3, 2020

Study Start

January 1, 2008

Primary Completion

December 1, 2017

Study Completion

April 30, 2020

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

EG(1)