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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

November 12, 2009
September 9, 2016
September 2009
December 2016   (final data collection date for primary outcome measure)
  • 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.
The primary objective of this protocol is to determine the frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung. The primary endpoint of this protocol is the mutation rate. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01014286 on ClinicalTrials.gov Archive Site
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.
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. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lung Cancer Mutation Consortium Protocol
Lung Cancer Mutation Consortium Protocol
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.
Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
Biopsy remnant tissue
Probability Sample
Stage IV adenocarcinoma of the lung who have undergone biopsy with remnant tissue
Adenocarcinoma of Lung, Stage IV
Not Provided
Advanced Adenocarcinoma
Stage IV adenocarcinoma who have undergone biopsy with remnant tissue.
Kris MG, Johnson BE, Berry LD, Kwiatkowski DJ, Iafrate AJ, Wistuba II, Varella-Garcia M, Franklin WA, Aronson SL, Su PF, Shyr Y, Camidge DR, Sequist LV, Glisson BS, Khuri FR, Garon EB, Pao W, Rudin C, Schiller J, Haura EB, Socinski M, Shirai K, Chen H, Giaccone G, Ladanyi M, Kugler K, Minna JD, Bunn PA. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014 May 21;311(19):1998-2006. doi: 10.1001/jama.2014.3741.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1100
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014286
09-0756
No
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Free to Breathe
Study Director: Paul Bunn, M.D. University of Colorado, Denver
University of Colorado, Denver
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP