Molecular Epidemiology of Lung Adenocarcinoma in Multi-ethnic Asian Phenotype

January 21, 2013 updated by: National University Hospital, Singapore
Lung Cancer continues to be the major cause of cancer-related mortality in Singapore. Non-small cell lung cancer (NSCLC) accounts for 75% of lung cancers and adenocarcinoma is the most common histological subtype. Although cigarette-smoking is the main cause of lung cancer, more than a third afflicted in Singapore are never-smokers and 69% affect females. For the majority who present with advanced NSCLC, chemotherapy is the mainstay of treatment. Despite advances made with newer chemotherapeutic agents, it is apparent that the benefit of conventional chemotherapy has plateaued. Efforts toward developing novel treatments based on growing understanding of molecular oncology have yielded drugs that target vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR). They have expanded treatment options for patients with advanced NSCLC. However, monoclonal antibody to VEGF is contraindicated in patients with squamous cell carcinoma due to increased incidence of fatal hemoptysis. EGFR tyrosine kinase inhibitors (EGFR-TKI) appear promising but only 40% of east-asian female never-smokers with lung adenocarcinoma harbour EGFR gene mutations. Estrogen, KRAS, BRAF, ERBE and other genetic mutations can confound response. Molecular data obtained from Caucasian and predominantly east-asian population may not apply to our multi-ethnic groups and our aim is to determine the molecular characteristics of our multi-ethnic asian phenotypes to better understand the process of carcinogenesis and treatment response as well as identify potential novel targets for future drug development. Paraffin-embedded tissues are recalled, and DNA is extracted for mutational analysis, which will be correlated to patient demographics, treatment and outcome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Lung cancer is a malignant disease of heterogeneous histology and is divided into 2 major groups; small cell lung cancer and non-small cell lung cancer (NSCLC). NSCLC accounts for 75% of lung cancers, and can exhibit different pathways of resistance during treatment. It is increasingly apparent that effective treatment of NSCLC will require multiple drugs that attack different targets. This realization sets the stage for future individualized therapies that will depend on the molecular characteristics of NSCLC to target various pathways.

AIMS

  1. Describe the molecular epidemiology of lung adenocarcinoma in multi-ethnic asian phenotype.
  2. Correlate tumor molecular characteristics with patient demographics and outcome to better understand carcinogenesis as well as in the discovery of novel targets for future drug development.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Hospital/ National University of Singapore
        • Contact:

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asian ethnicity
  • Age > 21 years old
  • Non-smoker
  • Metastatic pleural effusion due to lung adenocarcinoma
  • Good ECOG status (ECOG 1-2) fit to undergo pleuroscopy and biopsy and agreeable for palliative chemotherapy and or EGFR-TKI

Exclusion Criteria:

  • Non-Asian ethnicity
  • Age < 21 years old
  • Smoker
  • Subjects with poor ECOG status or unwilling to undergo pleuroscopy and biopsy
  • Subjects not suitable to receive palliative chemotherapy or EGFR-TKI
  • All other histological subtypes and stages of disease

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Descriptive study of our patients with lung adenocarcinoma. Identify novel molecular characteristics so that potential drug development can be reached.
Time Frame: 6 years
6 years

Collaborators and Investigators

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

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Pyng Lee, MD, National University Hospital, Singapore

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

December 1, 2010

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 1, 2013

First Submitted That Met QC Criteria

January 21, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 21, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRB-B/11/139

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.

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