Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01580982
• Other study ID #: 11-1621.cc
• Status: Recruiting
• Start date: January 23, 2012
• Est. completion date: January 30, 2027

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: Brandi Kubala
• Phone: 303-724-1657
• Email: brandi.kubala[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: January 30, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Lung Neoplasms

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies		To be determined upon funding