Molecular Epidemiology of Lung Adenocarcinoma in Multi-ethnic Asian Phenotype

This study is currently recruiting participants.
Verified December 2012 by National University Hospital, Singapore
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01774526
First received: January 1, 2013
Last updated: January 21, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Lung Cancer
Other: Characterise the molecular epidemiology of lung adenocarcinoma in multi-ethnic asian phenotypes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Molecular Epidemiology of Lung Adenocarcinoma in Multi-ethnic Asian Phenotype

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Descriptive study of our patients with lung adenocarcinoma. Identify novel molecular characteristics so that potential drug development can be reached. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774526

Contacts
Contact: Pyng Lee, MD +65-67795555 mdclp@nus.edu.sg

Locations
Singapore
National University Hospital/ National University of Singapore Recruiting
Singapore, Singapore
Contact: Pyng Lee, MD    +65-67795555    mdclp@nus.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Pyng Lee, MD National University Hospital, Singapore
  More Information

Publications:

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01774526     History of Changes
Other Study ID Numbers: DSRB-B/11/139
Study First Received: January 1, 2013
Last Updated: January 21, 2013
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014