Lymph Node Ratio and Kras Mutation in R Colon Cancer

April 8, 2020 updated by: Mansoura University

Lymph Node Ratio and Kras Mutation in Risk Stratification of Colon Cancer

clinical impact of LN ratio with Kras expression in colon cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

LNR and K ras were evaluated with correlated with different clinicopathological parameters of the patients, PFS and OS.

Study Type

Interventional

Enrollment (Actual)

433

Phase

  • Phase 3

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
    • Ad Daqahliyah
      • Mansoura, Ad Daqahliyah, Egypt, 35516
        • Mansoura University Oncology Center

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

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage III colon cancer

Exclusion Criteria:

  • Stage I, II, IV

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients
LNR measured by (number of metastatic lymph nodes/total number of lymph nodes excised). and K ras (polymerase chain reaction (PCR) and pyrosequencing targeted for KRAS codons 12-13 was performed )
Device: k ras
K ras
Drug: Panitumumab
vectibex in stage iv
Other Names:
  • vectibex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LNR and K ras were evaluated with correlated with different clinicopathological parameters (Gender, CEA, tumor size, tumor grade and response to treatment).
Time Frame: 2 years
impact on response
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LNR and K ras were evaluated and ASSOCIATION with PFS and OS.
Time Frame: 2 years
impact on survival
2 years

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Chair: Tawfik A Elkhodary, MD, Oncology center Mansoura University

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)

March 10, 2017

Primary Completion (Actual)

August 25, 2019

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 20202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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