NCT04342676

Brief Summary

clinical impact of LN ratio with Kras expression in colon cancer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

April 3, 2020

Last Update Submit

April 8, 2020

Conditions

Colon Cancer Stage III

Outcome Measures

Primary Outcomes (1)

  • LNR and K ras were evaluated with correlated with different clinicopathological parameters (Gender, CEA, tumor size, tumor grade and response to treatment).

    impact on response

    2 years

Secondary Outcomes (1)

  • LNR and K ras were evaluated and ASSOCIATION with PFS and OS.

    2 years

Study Arms (1)

patients

EXPERIMENTAL

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 rasDrug: Panitumumab

Interventions

k rasDEVICE

K ras

patients
PanitumumabDRUG

vectibex in stage iv

Also known as: vectibex
patients

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stage III colon cancer

You may not qualify if:

  • Stage I, II, IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Oncology Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Tawfik A Elkhodary, MD

    Oncology Center Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 13, 2020

Study Start

March 10, 2017

Primary Completion

August 25, 2019

Study Completion

August 26, 2019

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

after publication

Locations

EG(1)