Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer

Recruiting

• Conditions: Lung Neoplasms

• Registration Number: NCT01580982
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Study Timeline

• Study Start: 2012-01-23
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

1. Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies
2. Aged 18 years or older
3. 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.
4. Patients must have the ability to understand and willingness to sign an informed consent document.

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers.	To be determined upon funding

Secondary Outcome Measures

Name	Time	Method
To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies	To be determined upon funding

Trial Locations

Locations (1)

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States