Lung Cancer Mutation Consortium Protocol

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Adenocarcinoma of Lung, Stage IV

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01014286

09-0756.cc

RC2CA148394 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,100 participants in 1 patient group

Advanced Adenocarcinoma

Description:

Stage IV adenocarcinoma who have undergone biopsy with remnant tissue.