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
This study is currently recruiting participants.
Verified November 2012 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
ICORG- All Ireland Cooperative Oncology Research Group
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01721252
First received: October 24, 2012
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
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.
| Condition |
|---|
|
Non-small Cell Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:
Primary Outcome Measures:
- Value of a recently identified proteomic algorithm [ Time Frame: 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. ] [ Designated as safety issue: No ]Routine CT with RECIST/WHO assessment
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Screening/Baseline
- Routine blood tests (Haematology and Biochemistry) as per hospital practice
- Research serum sample for proteomic studies (10ml blood sample)
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- Patients younger than 18 years of age
- Patients not foreseen to receive TarcevaTM treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721252
Locations
| Ireland | |
| Cork University Hospital | Recruiting |
| Cork, Ireland | |
| Contact: Contact Person +353 (0)21 4546400 | |
| Beaumont Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Contact Person (01) 809 3000 | |
| St James Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Contact Person (01) 410 3000 | |
| The Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Contact Person (01) 414 2000 | |
| Galway University Hospital | Recruiting |
| Galway, Ireland | |
| Contact: Contact Person 00 353 (0)91 524222 | |
| Mid-Western Regional Hospital | Recruiting |
| Limerick, Ireland | |
| Contact: Contact Person 061 301111 | |
| Our Lady Of Lourdes Hospital, Drogheda | Recruiting |
| Louth, Ireland | |
| Contact: Contact Person (041) 9837601 | |
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
More Information
No publications provided
| Responsible Party: | ICORG- All Ireland Cooperative Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT01721252 History of Changes |
| Other Study ID Numbers: | ICORG 08-41 |
| Study First Received: | October 24, 2012 |
| Last Updated: | November 1, 2012 |
| Health Authority: | Ireland: Health Information and Quality Authority |
Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
|
non-small cell lung cancer Erlotinib TarcevaTM proteomic signature |
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 Mitogens Erlotinib Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013