Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum

October 21, 2023 updated by: Abdallah Mohamed Taha Aly, South Valley University

Predictors of Disease Free Survival After Curative Cancer Rectum Surgery

Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome. This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A retrospective analysis of patients operated for cancer rectum with curative intent from.

Exclusion criteria will include patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, and death within 3 months. Incomplete patients' files and patients that lost follow-up will be excluded.

Demographic, histopathological, follow up and outcome data will be collected from completed patients' files. Demographics include age, gender, family history, and chief complaint at the presentation. Histopathological data include tumor grade, vascular-perineural invasion, the total number of lymph nodes removed, and positive lymph nodes.

Lymph node ratio will be defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in a histopathology specimen. Disease-free survival will be calculated for each patient based on the time of surgery to the time of recurrence detection.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Qinā, Egypt
        • Recruiting
        • Qena Faculty of Medicine, South Valley University Hospitals
        • Contact:
        • Principal Investigator:
          • Abdallah M Taha, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

- Patients who had curative surgery for cancer rectum.

Description

Inclusion Criteria:

  • Patients who had curative surgery for cancer rectum.

Exclusion Criteria:

  • Patients with familial adenomatous polyposis (FAP), multiple synchronous or metachronous rectal cancers, and death within 3 months
  • Patients that lost follow-up will be excluded.

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
Patients with cancer rectum underwent curative surgery
Procedure: curative surgery for cancer rectum
Curative surgery for cancer rectum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor recurrence
Time Frame: Through study completion, an average of 3 year
Presence of Tumor recurrence after curative surgery for cancer rectum.
Through study completion, an average of 3 year
Disease free survival.
Time Frame: up to 5 years
From date of surgery until the date of recurrence detection.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Principal Investigator: Abdallah M Taha, MD, South Valley University, Egypt.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 21, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 21, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU-MED-SUR011-4-23-4-621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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