Overview

This trial is active, not recruiting.

Condition adenocarcinoma of lung, stage iv
Sponsor University of Colorado, Denver
Collaborator Free to Breathe
Start date September 2009
End date December 2016
Trial size 1100 participants
Trial identifier NCT01014286, 09-0756

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective
Arm
Stage IV adenocarcinoma who have undergone biopsy with remnant tissue.

Primary Outcomes

Measure
Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
time frame: Five years
Rate of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
time frame: Five years

Secondary Outcomes

Measure
Associations between each mutation and clinical outcomes.
time frame: Two years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Lung Cancer Mutation Consortium Protocol
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.