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

This study has been completed.
Sponsor:
Collaborators:
Universiteit Antwerpen
AstraZeneca
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01260038
First received: December 13, 2010
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • testing turn around time (in days) [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
    how long does it take to get the mutation analysis result


Secondary Outcome Measures:
  • demographics [ Time Frame: baseline ] [ Designated as safety issue: No ]
    age, gender, tumor histology, smoking history

  • correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • correlation between family history with regards to cancer and EGFR-mutation status [ Time Frame: baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

At diagnosis a tumor sample is collected for histological evaluation, this sample will be used for the biomarker analysis.


Enrollment: 107
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

newly diagnosed patients with Non Small Cell Lung Cancer

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260038

Locations
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium, 2650
ZNA Middelheim - ZNA STER - ZNA Jan Palfijn
Antwerpen, Belgium
GZA Sint Vincentius - Sint Augustinus
Antwerpen, Belgium
AZ Monica
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
AstraZeneca
Investigators
Principal Investigator: Paul R Germonpre, MD UZA + Thoracale Oncologie Groep Antwerpen
  More Information

No publications provided

Responsible Party: Thoracale Oncologie Groep Antwerpen, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT01260038     History of Changes
Other Study ID Numbers: TOGA 1001
Study First Received: December 13, 2010
Last Updated: January 17, 2012
Health Authority: Belgium: Institutional Review Board

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
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014