Study in NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in Region Antwerp, Belgium. (HERMES)

January 17, 2012 updated by: University Hospital, Antwerp

Personalized 1st-line Treatment of Patients With NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in a Routine Practice Setting in Antwerp.

This is an observational study to evaluate the feasibility of the implementation of a personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the routine clinical care setting in the Antwerp region (Belgium).

Study Overview

Status

Completed

Conditions

Detailed Description

The favourable results of a number of phase III-trials with gefitinib in NSCLC patients with activating EGFR-mutations, have resulted in the licensing of gefitinib in this indication. This offers the prospect of a true personalized treatment of patients with NSCLC. Implementation of such a personalized treatment strategy is dependent both on the availability of adequate tumor samples for the EGFR-mutation analysis and on the timely reporting of the mutation analysis results. Ideally the results should be available in all patients within 2 weeks of the analysis request.

Study Type

Observational

Enrollment (Actual)

107

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

  • Belgium
      • Antwerpen, Belgium
        • AZ Monica
      • Antwerpen, Belgium
        • GZA Sint Vincentius - Sint Augustinus
      • Antwerpen, Belgium
        • ZNA Middelheim - ZNA STER - ZNA Jan Palfijn
      • Bornem, Belgium
        • AZ St Jozef Bornem en Willebroek
      • Brasschaat, Belgium
        • AZ Klina
      • Geel, Belgium
        • AZ St Dimpna
      • Herentals, Belgium
        • AZ St Elisabeth
      • Mol, Belgium
        • AZ Mol
      • Sint-Niklaas, Belgium
        • AZ Nikolaas
      • Turnhout, Belgium
        • AZ Turnhout
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

newly diagnosed patients with Non Small Cell Lung Cancer

Description

Inclusion Criteria:

  • age 18 years or above
  • newly diagnosed NSCLC
  • written informed consent
  • tumor sample available

Exclusion Criteria:

  • mixed histology of small cell and NSCLC

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
testing turn around time (in days)
Time Frame: up to 1 month
how long does it take to get the mutation analysis result
up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographics
Time Frame: baseline
age, gender, tumor histology, smoking history
baseline
correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status
Time Frame: baseline
baseline
correlation between family history with regards to cancer and EGFR-mutation status
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

University Hospital, Antwerp

Collaborators

AstraZeneca
Universiteit Antwerpen

Investigators

  • Principal Investigator: Paul R Germonpre, MD, UZA + Thoracale Oncologie Groep Antwerpen

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

November 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOGA 1001

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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