Lung Cancer Mutation Consortium Protocol

Active, not recruiting

• Conditions: Adenocarcinoma of Lung, Stage IV

• Registration Number: NCT01014286
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-16
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2016-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1100

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.

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Exclusion Criteria

1. Lung cancer histologies other than adenocarcinoma
2. Lack of adequate tissue.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.	Five years	The primary objective of this protocol is to determine the frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
Rate of oncogenic mutations in patients with advanced adenocarcinoma of the lung.	Five years	The primary endpoint of this protocol is the mutation rate.

Secondary Outcome Measures

Name	Time	Method
Associations between each mutation and clinical outcomes.	Two years	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.

Trial Locations

Locations (1)

University of Colorado Denver Cancer Center; 🇺🇸 Aurora, Colorado, United States