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Lung Cancer Mutation Consortium Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01014286
First received: November 12, 2009
Last updated: May 5, 2014
Last verified: May 2014

November 12, 2009
May 5, 2014
September 2009
September 2014   (final data collection date for primary outcome measure)
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: 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. 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
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 ]
Same as current
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 CLIA-certified lab.

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Biopsy remnant tissue

Probability Sample

Stage IIIB/IV adenocarcinoma of the lung who have undergone biopsy with remnant tissue.

Stage IIIB/IV Adenocarcinoma
Other: No intervention
No study intervention for this trial
Advanced Adenocarcinoma
Stage IIIB/IV adenocarcinoma who have undergone biopsy with remnant tissue.
Intervention: Other: No intervention
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.
 
Recruiting
1000
September 2014
September 2014   (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. Oral and written informed consent.

Exclusion Criteria:

  1. Any individual who does not give oral and written consent for participation.
  2. Lung cancer histologies other than adenocarcinoma
  3. Lack of adequate tissue.
Both
18 Years and older
No
Contact: Kelly Kugler, B.S. 303-724-4168 kelly.kugler@ucdenver.edu
Contact: Mary Jackson 303-724-1650 mary.k.jackson@ucdenver.edu
United States
 
NCT01014286
09-0756
No
University of Colorado, Denver
University of Colorado, Denver
National Cancer Institute (NCI)
Study Director: Paul Bunn, M.D. University of Colorado, Denver
University of Colorado, Denver
May 2014

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