Non Small Cell Lung Cancer Clinical Trial
— HERMESOfficial title:
Personalized 1st-line Treatment of Patients With NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in a Routine Practice Setting in Antwerp.
Verified date | January 2012 |
Source | University Hospital, Antwerp |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Institutional Review Board |
Study type | Observational |
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).
Status | Completed |
Enrollment | 107 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | 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 | Universitair Ziekenhuis Antwerpen | Edegem | Antwerpen |
Belgium | AZ St Dimpna | Geel | |
Belgium | AZ St Elisabeth | Herentals | |
Belgium | AZ Mol | Mol | |
Belgium | AZ Nikolaas | Sint-Niklaas | |
Belgium | AZ Turnhout | Turnhout |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | AstraZeneca, Universiteit Antwerpen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | testing turn around time (in days) | how long does it take to get the mutation analysis result | up to 1 month | No |
Secondary | demographics | age, gender, tumor histology, smoking history | baseline | No |
Secondary | correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status | baseline | No | |
Secondary | correlation between family history with regards to cancer and EGFR-mutation status | baseline | No |
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