Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival

December 27, 2022 updated by: Abdallah Mohamed Taha Aly, South Valley University

Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival: An Alternative Not a Substitute

This study was conducted to compare the significance of lymph node ratio and absolute count of positive lymph node count on overall survival in patients with rectal cancer who underwent resection with curative intent

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective cohort study carried on 229 patients with non-metastatic rectal cancer, admitted in tertiary hospitals along 10 years, between 2012 to 2022, and underwent radical resection surgery with curative intent.

Exclusion criteria included patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, early post-operative recurrence or death within 3 months. Demographic, histopathological, follow up and outcome data were collected.

Demographics included age, gender, family history, and chief complaint at presentation. Histopathological data included tumor site, grade, vascular-perineural invasion, total number of lymph nodes removed, and positive lymph nodes.

Lymph node ratio was defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in histopathology specimen. Survival was calculated for each patient based on time of surgery to time of death

Statistical analysis will be used to evaluate the effect of lymph node ratio on overall survival.

Study Type

Observational

Enrollment (Actual)

229

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

  • Egypt
      • Qinā, Egypt
        • Qena Faculty of Medicine, South Valley University Hospitals

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

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with rectal cancer that were admitted in tertiary hospitals and underwent curative rectal resection. Patients' files were reviewed, and the data were collected and tabulated.

Description

Inclusion Criteria:

  • Patient with rectal cancer of stage I-III.
  • patients underwent radical resection with curative intent.

Exclusion Criteria:

  • Patients with Familial Adenomatous Polyposis, multiple synchronous or metachronous rectal cancers.
  • Early post-operative recurrence, or death within 3 months.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: up to 10 years (From date of surgery to the date date of death)
Survival was calculated for each patient based on time of surgery to time of death.
up to 10 years (From date of surgery to the date date of death)

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, Egypt, South Valley University, Faculty of Medicine

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)

January 1, 2012

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU-MED-SUR011-4-22-10-464

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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