Lung Cancer Mutation Consortium Protocol

Adenocarcinoma of Lung, Stage IV Clinical Trial

Official title:

Lung Cancer Mutation Consortium Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01014286
• Other study ID #: 09-0756.cc
• Status: Active, not recruiting
• Start date: September 16, 2009
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: September 30, 2024
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Adenocarcinoma of Lung, Stage IV

Locations

Country	Name	City	State
United States	University of Colorado Denver Cancer Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Five years
Primary	Rate of oncogenic mutations in patients with advanced adenocarcinoma of the lung.	The primary endpoint of this protocol is the mutation rate.	Five years
Secondary	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.	Two years