Lung Cancer Mutation Consortium Protocol

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01014286

Enrollment

1100

Registered

2009-11-16

Start date

2009-09-16

Completion date

2019-01-12

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of Lung, Stage IV

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results