Tarceva. ICORG 08-41
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
1 other identifier
observational
200
1 country
7
Brief Summary
The aim of this study is to determine prospectively the value of a recently identified proteomic signature in identifying those patients with lung cancer, who are likely to benefit from and respond favourably to erlotinib therapy. This is a prospective study of serum proteomics as a predictor of response to erlotinib therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 24, 2012
CompletedFirst Posted
Study publicly available on registry
November 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedMarch 30, 2015
March 1, 2015
3.7 years
October 24, 2012
March 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Eligibility Criteria
Any patient (18 years of age or older) diagnosed with non-small cell lung cancer at any stage who is to be treated with erlotinib.
You may qualify if:
- years of age or older
- Any patient who is suited to receive CT scans as part of his/her routine care
- Ability to understand and the willingness to sign a written informed consent, given according to ICH/GCP, and national/local regulations. A signed informed consent must be obtained prior to any study specific procedures
- Planned treatment with erlotinib.
You may not qualify if:
- Patients younger than 18 years of age
- Patients not foreseen to receive TarcevaTM treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
St James Hospital
Dublin, Ireland
The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Mid-Western Regional Hospital
Limerick, Ireland
Our Lady Of Lourdes Hospital, Drogheda
Louth, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2012
First Posted
November 5, 2012
Study Start
December 1, 2009
Primary Completion
August 1, 2013
Last Updated
March 30, 2015
Record last verified: 2015-03