Lung Cancer Mutation Consortium Protocol

NCT01014286 | Completed

• 2 other identifiers: 09-0756.ccRC2CA148394
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of Lung, Stage IV

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Associations between each mutation and clinical outcomes.

  Two years

Study Arms (1)

Advanced Adenocarcinoma

Stage IV adenocarcinoma who have undergone biopsy with remnant tissue.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Subjects (=\> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung.
• Diagnosed May 2012 or later
• Oral and written informed consent.

You may not qualify if:

• Lung cancer histologies other than adenocarcinoma
• Lack of adequate tissue.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Denver Cancer Center

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Kris MG, Johnson BE, Berry LD, Kwiatkowski DJ, Iafrate AJ, Wistuba II, Varella-Garcia M, Franklin WA, Aronson SL, Su PF, Shyr Y, Camidge DR, Sequist LV, Glisson BS, Khuri FR, Garon EB, Pao W, Rudin C, Schiller J, Haura EB, Socinski M, Shirai K, Chen H, Giaccone G, Ladanyi M, Kugler K, Minna JD, Bunn PA. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014 May 21;311(19):1998-2006. doi: 10.1001/jama.2014.3741.

  PMID: 24846037 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy remnant tissue

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Paul Bunn, M.D.

  University of Colorado, Denver

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 16, 2009
• Study Start: September 16, 2009
• Primary Completion: September 1, 2016
• Study Completion: January 12, 2019
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)