We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer

This study is currently recruiting participants.
Verified August 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580982
First Posted: April 19, 2012
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  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: Observational Model: Other
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 ]

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 ]

Biospecimen Retention:   Samples With DNA
Tumor tissue will be acquired from either archival or de novo biopsy material

Estimated Enrollment: 175
Actual Study Start Date: January 23, 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01580982     History of Changes
Other Study ID Numbers: 11-1621.cc
First Submitted: April 17, 2012
First Posted: April 19, 2012
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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