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NCT05221684 Clinical Trial

Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer

Recurrence Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05221684
Other study ID # LN ratio in rectal cancer
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 9, 2020
Est. completion date December 31, 2022

Study information
Verified date January 2022
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date December 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Lymph node harvesting
Lymph node harvesting after radical resection for rectal cancer with curative intent

Locations
Country Name City State
Egypt Mansoura Faculty of Medicine Mansoura Dakahliya

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lymph node value Value in prediction of oncological outcomes one year
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