Lung Cancer Mutation Consortium Protocol

University of Colorado, Denver1,100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,100

Conditions

Adenocarcinoma of Lung, Stage IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.

The primary objective of this protocol is to determine the 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.

The primary endpoint of this protocol is the mutation rate.

Time frame: Five years

Secondary Outcomes

Associations between each mutation and clinical outcomes.

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