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Completed

NCT Number: NCT01260038

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

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).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Antwerpen, Edegem, Antwerpen, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • AstraZeneca
  • Universiteit Antwerpen

Registry information

Official study title

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

Acronym: HERMES

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2010
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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