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Recruiting NCT01580982

Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer

Observational Lung Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Neoplasms. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung and Other Thoracic Cancers

Overview

The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined from tumor tissue or tumor cell lines derived from available archival samples and/or from standard-of-care re-biopsy upon suspected tumor progression.

Detailed description

To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies.

Primary outcome measures

  • To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. [Time frame: To be determined upon funding]
Secondary outcome measures (1)
  • To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies [Time frame: To be determined upon funding]

Eligibility criteria

Inclusion criteria

  • Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies
  • Aged 18 years or older
  • Either a) have suspected tumor progression or other condition that dictates a standard-of-care palliative, therapeutic, or diagnostic intervention including but not limited to procedures such as bronchoscopic biopsy, computed tomography (CT) or ultra-sound (US)-guided biopsy, thoracentesis, video assisted thoracoscopic (VATS) pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor specimen appropriate molecular analysis or b) have previously had biopsy/surgical intervention with tumor tissue at University of Colorado or an outside institution available for medullar analysis.
  • Patients must have the ability to understand and willingness to sign an informed consent document.

Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • University of Colorado Cancer Center — Aurora

Identifiers

NCT: NCT01580982 · 11-1621.cc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗