- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00899262
Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers
Early Detection of Lung Cancer: Metabolic Biomarkers for High Risk Screening (MEDLUNG)
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).
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Wales
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Llanelli, Wales, Storbritannia, SA14 8QF
- Rekruttering
- Prince Philip Hospital
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Ta kontakt med:
- Contact Person
- Telefonnummer: 44-1554-75-65-67
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Swansea, Wales, Storbritannia, SA2 8PP
- Rekruttering
- South West Wales Cancer Institute
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Ta kontakt med:
- Paul D. Lewis, BSc, PhD
- Telefonnummer: 44-1792-295-222
- E-post: p.d.lewis@swansea.ac.uk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Hva måler studien?
Primære resultatmål
Resultatmål |
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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
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Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Paul D. Lewis, BSc, PhD, Swansea University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000599372
- SWWCI-MEDLUNG
- UKCRN-4682
- EU-20862
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