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OpenTrials
Completed

NCT Number: NCT01721252

Tarceva. ICORG 08-41

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cork University Hospital, Cork, Ireland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Routine CT with RECIST/WHO assessment

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
First posted
Nov 5, 2012
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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