Prospective Evaluation of a Proteomic Signature Developed to Identify Patients Likely to Benefit From Erlotinib (TarcevaTM), an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Used in the Treatment of Non-small Cell Lung Cancer
Screening/Baseline
1. Routine blood tests (Haematology and Biochemistry) as per hospital practice
2. Research serum sample for proteomic studies (10ml blood sample)
3. Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size
2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO
assessment
4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO
assessment
1 year Post Commencement of Treatment with erlotinib (as per current standard of care):
Routine CT with RECIST/WHO assessment
Response Assessment: CT scans at baseline, at 2 and 4 months post commencement of therapy
and one year after treatment with erlotinib will be analyzed with the emphasis on
identification of disease progression.
Follow Up: Subsequent follow-up as per routine.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Value of a recently identified proteomic algorithm
Routine CT with RECIST/WHO assessment
Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.
No
Ireland: Health Information and Quality Authority
ICORG 08-41
NCT01721252
December 2009
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