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

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. Identifier: NCT01260038
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : January 18, 2012
Universiteit Antwerpen
Information provided by:
University Hospital, Antwerp

Brief Summary:
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).

Condition or disease
Non Small Cell Lung Cancer

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
Actual Enrollment : 107 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Personalized 1st-line Treatment of Patients With NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in a Routine Practice Setting in Antwerp.
Study Start Date : November 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. testing turn around time (in days) [ Time Frame: up to 1 month ]
    how long does it take to get the mutation analysis result

Secondary Outcome Measures :
  1. demographics [ Time Frame: baseline ]
    age, gender, tumor histology, smoking history

  2. correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status [ Time Frame: baseline ]
  3. correlation between family history with regards to cancer and EGFR-mutation status [ Time Frame: baseline ]

Biospecimen Retention:   None Retained
At diagnosis a tumor sample is collected for histological evaluation, this sample will be used for the biomarker analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
newly diagnosed patients with Non Small Cell Lung Cancer

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

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 identifier (NCT number): NCT01260038

Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium, 2650
AZ Monica
Antwerpen, Belgium
GZA Sint Vincentius - Sint Augustinus
Antwerpen, Belgium
ZNA Middelheim - ZNA STER - ZNA Jan Palfijn
Antwerpen, Belgium
AZ St Jozef Bornem en Willebroek
Bornem, Belgium
AZ Klina
Brasschaat, Belgium
AZ St Dimpna
Geel, Belgium
AZ St Elisabeth
Herentals, Belgium
AZ Mol
Mol, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
AZ Turnhout
Turnhout, Belgium
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Principal Investigator: Paul R Germonpre, MD UZA + Thoracale Oncologie Groep Antwerpen

Responsible Party: Thoracale Oncologie Groep Antwerpen, Universiteit Antwerpen Identifier: NCT01260038     History of Changes
Other Study ID Numbers: TOGA 1001
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by University Hospital, Antwerp:
Non Small Cell Lung Cancer
observational study
EGFR mutation analysis
EGFR mutation status
testing turn around time

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases