Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer

Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer: a Retrospective Cohort

This study aims to evaluate the value of the LNR as a prognostic indicator in patients with rectal cancer who offered total mesorectal excision.

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrence
• Intervention / Treatment: Procedure: Lymph node harvesting

Detailed Description

Patients and methods Study design and setting This is a retrospective review of prospectively collected and maintained database of patients with CRC admitted in the Oncology Center of Mansoura University (OCMU), the Colorectal Surgery Unit of Mansoura University Hospitals, and the Department of General Surgery of Alexandria University.

Selection criteria Patients of either gender aged 18 years or above who presented with rectal cancer of any stage will be included in the study. We will exclude patients with patients younger than 18 years; patients with synchronous colon cancer; synchronous liver, pulmonary or bones metastasis; or synchronous gastrointestinal cancer; or patients who were lost to follow-up.

Study endpoints The primary endpoint of the study is to assess the value of lymph node ratio (LNR) on the oncological outcomes.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Egypt
  • Dakahliya
    • Mansoura, Dakahliya, Egypt, 35516
      • Mansoura Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with rectal cancer TNM stage I-III Who underwent surgery with curative intent

Description

Inclusion Criteria:

• rectal cancer of TNM stage I-III
• underwent radical resection with curative intent

Exclusion Criteria:

• synchronous colon cancer
• synchronous gastrointestinal cancer
• underwent palliative resection
• presented with intestinal obstruction
• those lost to follow-up.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymph node value	Value in prediction of oncological outcomes	one year

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mostafa Shalaby, Mansoura Faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 23, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: LN ratio in rectal cancer

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