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Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer

Sponsor
Mansoura University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05221684
Collaborator
(none)
300
Enrollment
1
Location
30.7
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer: a Retrospective Cohort
Actual Study Start Date :
Jun 9, 2020
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Lymph node value [one year]

    Value in prediction of oncological outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura Faculty of Medicine Mansoura Dakahliya Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Principal Investigator: Mostafa Shalaby, Mansoura Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mostafa shalaby, MD, MSc, PhD, Lecturer of Colorectal Surgery, Mansoura University
ClinicalTrials.gov Identifier:
NCT05221684
Other Study ID Numbers:
  • LN ratio in rectal cancer
First Posted:
Feb 3, 2022
Last Update Posted:
Feb 3, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Recurrence

Study Results

No Results Posted as of Feb 3, 2022