NCT00899262

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

August 26, 2013

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

May 9, 2009

Last Update Submit

August 23, 2013

Conditions

Keywords

lung cancertobacco use disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Prince Philip Hospital

Llanelli, Wales, SA14 8QF, United Kingdom

RECRUITING

South West Wales Cancer Institute

Swansea, Wales, SA2 8PP, United Kingdom

RECRUITING

Related 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.

MeSH Terms

Conditions

Lung NeoplasmsTobacco Use Disorder

Interventions

ImmunohistochemistrySpectroscopy, Fourier Transform Infrared

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesSpectrophotometry, InfraredSpectrophotometryPhotometryChemistry Techniques, AnalyticalSpectrum Analysis

Study Officials

  • Paul D. Lewis, BSc, PhD

    Swansea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Last Updated

August 26, 2013

Record last verified: 2009-06

Locations