Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lymph Node Ratio and Kras Mutation in R Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342676
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:
clinical impact of LN ratio with Kras expression in colon cancer

Condition or disease Intervention/treatment Phase
Colon Cancer Stage III Device: k ras Drug: Panitumumab Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Lymph Node Ratio and Kras Mutation in Risk Stratification of Colon Cancer
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : August 25, 2019
Actual Study Completion Date : August 26, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

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 Name: vectibex




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. LNR and K ras were evaluated and ASSOCIATION with PFS and OS. [ Time Frame: 2 years ]
    impact on survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage III colon cancer

Exclusion Criteria:

  • Stage I, II, IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342676


Locations
Layout table for location information
Egypt
Mansoura University Oncology Center
Mansoura, Ad Daqahliyah, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
Layout table for investigator information
Study Chair: Tawfik A Elkhodary, MD Oncology Center Mansoura University
Layout table for additonal information
Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT04342676    
Other Study ID Numbers: IRB 20202
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: after publication

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents