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Lung Cancer Mutation Consortium Protocol

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Free to Breathe
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01014286
First received: November 12, 2009
Last updated: September 9, 2016
Last verified: September 2016
  Purpose
The primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. As future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. Future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. A secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Condition
Adenocarcinoma of Lung, Stage IV

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Lung Cancer Mutation Consortium Protocol

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung. [ Time Frame: Five years ] [ Designated as safety issue: No ]
    The primary objective of this protocol is to determine the frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.

  • Rate of oncogenic mutations in patients with advanced adenocarcinoma of the lung. [ Time Frame: Five years ] [ Designated as safety issue: No ]
    The primary endpoint of this protocol is the mutation rate.


Secondary Outcome Measures:
  • Associations between each mutation and clinical outcomes. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    The secondary objectives of this protocol are to study the associations between each mutation and clinical outcomes, e.g., survival, clinical features, e.g. smoking status, age, and other mutation.


Biospecimen Retention:   Samples With DNA
Biopsy remnant tissue

Enrollment: 1100
Study Start Date: September 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Advanced Adenocarcinoma
Stage IV adenocarcinoma who have undergone biopsy with remnant tissue.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stage IV adenocarcinoma of the lung who have undergone biopsy with remnant tissue
Criteria

Inclusion Criteria:

  1. Subjects (=> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung.
  2. Diagnosed May 2012 or later
  3. Oral and written informed consent.

Exclusion Criteria:

  1. Lung cancer histologies other than adenocarcinoma
  2. Lack of adequate tissue.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014286

Locations
United States, Colorado
University of Colorado Denver Cancer Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Free to Breathe
Investigators
Study Director: Paul Bunn, M.D. University of Colorado, Denver
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01014286     History of Changes
Other Study ID Numbers: 09-0756 
Study First Received: November 12, 2009
Last Updated: September 9, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 23, 2016