Lung Cancer Mutation Consortium Protocol

January 9, 2025 updated by: University of Colorado, Denver
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Stage IV adenocarcinoma of the lung who have undergone biopsy with remnant tissue

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Advanced Adenocarcinoma
Stage IV adenocarcinoma who have undergone biopsy with remnant tissue.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associations between each mutation and clinical outcomes.
Time Frame: 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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Director: Paul Bunn, M.D., University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 16, 2009

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

January 12, 2019

Study Registration Dates

First Submitted

November 12, 2009

First Submitted That Met QC Criteria

November 13, 2009

First Posted (Estimated)

November 16, 2009

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0756.cc
  • RC2CA148394 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adenocarcinoma of Lung, Stage IV

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