Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers

Lung Cancer Clinical Trial

Official title:

Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00899262
• Other study ID #: CDR0000599372
• Secondary ID: SWWCI-MEDLUNGUKC
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: August 23, 2013
• Start date: April 2008

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

RATIONALE: Collecting and storing samples of sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy volunteers (both smokers and non-smokers).

Description:

OBJECTIVES:

• To test and make a preliminary assessment of the sensitivity and specificity of Fourier transform infrared technology (FTIR) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers.

• To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.

OUTLINE: This is a multicenter study.

Sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. Sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. Samples are also examined for metabolic biomarkers using Fourier transform infrared spectroscopy (FTIR) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). These molecular biomarkers, which are detected within FTIR spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. Additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data.

All study participants are followed annually.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

• Diagnosis of lung cancer

• At high risk for developing lung cancer

• Non-high-risk smoking or non-smoking volunteer (control)

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

N/A

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Tobacco Use Disorder

Intervention

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

• sputum cytology

Procedure:
• Fourier transform infrared spectroscopy

• diagnostic bronchoscopy

Locations

Country	Name	City	State
United Kingdom	Prince Philip Hospital	Llanelli	Wales
United Kingdom	South West Wales Cancer Institute	Swansea	Wales

Sponsors (1)

Lead Sponsor	Collaborator
South West Wales Cancer Institute

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Lewis PD, Lewis KE, Ghosal R, Bayliss S, Lloyd AJ, Wills J, Godfrey R, Kloer P, Mur LA. Evaluation of FTIR spectroscopy as a diagnostic tool for lung cancer using sputum. BMC Cancer. 2010 Nov 23;10:640. doi: 10.1186/1471-2407-10-640. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of a cost-effective, high-throughput, and non-invasive screening test using Fourier transform infrared technology for detection of early lung cancer in sputum of high-risk people			No
Primary	Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages			No