Early-onset Rectal Cancer | NCT04496765

Studies
Early-onset Rectal Cancer

NCT04496765

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Aug 3, 2020Actual

Enrollment

244Actual

Phase

Not provided

Conditions

Rectal Cancer

Interventions

Total mesorectal excision

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2008Actual

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

Jul 29, 2020

First Submission Date that Met QC Criteria

Jul 31, 2020

First Posted Date

Aug 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2020

Last Update Posted Date

Aug 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

244Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
< 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

Name	Type	Description	Arm Group Labels	Other Names
Total mesorectal excision	Procedure	Radical resection of rectal cancer and draining lymph nodes	< 40 years > 40 years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local recurrence	recurrence of rectal cancer within the anatomic vicinity of the pelvis	36 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sameh H Emile	Mansoura University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital		Al Mansurah	Dakahlia Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided