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
  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 CLIA-certified lab.


Condition Intervention
Stage IIIB/IV Adenocarcinoma
Other: No intervention

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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Biopsy remnant tissue


Estimated Enrollment: 1000
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Advanced Adenocarcinoma
Stage IIIB/IV adenocarcinoma who have undergone biopsy with remnant tissue.
Other: No intervention
No study intervention for this trial

  Eligibility

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

Stage IIIB/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. 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.
  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

Contacts
Contact: Kelly Kugler, B.S. 303-724-4168 kelly.kugler@ucdenver.edu
Contact: Mary Jackson 303-724-1650 mary.k.jackson@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly Kugler, B.S.    303-724-4168    kelly.kugler@ucdenver.edu   
Contact: Mary Jackson    303-724-1650    mary.k.jackson@ucdenver.edu   
Principal Investigator: Paul Bunn, M.D.         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Study Director: Paul Bunn, M.D. University of Colorado, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional 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: May 5, 2014
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 August 20, 2014