Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer

This study is currently recruiting participants.
Verified June 2013 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01580982
First received: April 17, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.


Condition
Lung Neoplasms

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung and Other Thoracic Cancers

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor tissue will be acquired from either archival or de novo biopsy material


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients considered for this study would be undergoing a standard care procedure

Criteria

Inclusion Criteria:

  1. Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies
  2. Aged 18 years or older
  3. Either be: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, CT or 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:

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580982

Contacts
Contact: Mary K Jackson 303-724-1650 mary.k.jackson@ucdenver.edu

Locations
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Mary K. Jackson    303-724-1650    mary.k.jackson@ucdenver.edu   
Principal Investigator: Robert C Doebele, MD,Ph.D         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Robert C. Doebele, MD, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01580982     History of Changes
Other Study ID Numbers: 11-1621
Study First Received: April 17, 2012
Last Updated: June 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Oncogenes
Lung and Other Thoracic Cancers

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014