- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00858520
Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer
Serum, Plasma, DNA and Tissue Bank of Patients With Chronic Obstructive Pulmonary Disease, Lung Cancer and Smoking Controls.
A biobank of Serum, plasma, DNA samples together with clinical information including specific questionnaires, complete pulmonary function and chest CT-scan, is prospectively collected in patients seen at the investigators' clinical service.
The objective is to study candidate gene pathways in COPD and or lung cancer and to associate them with the clinical characteristics and phenotypes of COPD/emphysema and lung cancer.
In subgroups of well characterised patients, other biological materials are also collected (lung tissue biopsies, peripheral blood mononuclear cells).
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
All patients with a smoking history of at least 15 pack years, an minimal age of 50 years and an recent available CT scan are enrolled.
All subjects with a diagnosis of lung cancer are also collected (irrespective of age and smoking behavior).
In addition the investigators collect:
- specific questionnaires (MRC, CCQ and smoking history)
- medical and professional history
- complete pulmonary function (spirometry, bodyplethysmography and diffusing capacity)
- serum, plasma and DNA samples.
In specific subgroups the investigators also collect:
- Peripheral blood mononuclear cells
- Lung tissue - if available - from a surgical procedure (lung transplantation or lobectomy)
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Flanders
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Leuven, Flanders, Belgien, 3000
- Rekruttering
- Katholieke Universiteit Leuven
-
Kontakt:
- Wim Janssens, Prof
- Telefonnummer: 032 (16) 34 68 00
- E-mail: wim.janssens@uz.kuleuven.ac.be
-
Underforsker:
- Marc Decramer, MD. PhD.
-
Underforsker:
- Diether Lambrechts, PhD
-
Underforsker:
- Paul Deleyn, MD PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria for smokers:
- A smoking history of at least 15 pack years and age of 50 years or older
- Complete pulmonary function on day of visit
- Chest CT-scan within one year of enrollment
- 4 weeks from exacerbation
Exclusion Criteria for smokers:
- Less than 15 pack years
- Younger than 50 year
- Other pulmonary diseases interfering with CT or pulmonary function
- Asthma
Inclusion Criteria for lung cancer patients:
- new diagnosis of proven lung cancer
- chest CT scan within 2 months of enrollment
- Complete pulmonary function
Exclusion Criteria for lung cancer patients
- not able to perform pulmonary function
- Absence of histological diagnosis of lung cancer
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Smoking controls
Smokers without lung cancer and without COPD
|
|
COPD patients
Smokers with COPD but without lung cancer
|
|
Lung cancer patients
smokers - never smokers with lung cancer
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serological, cytological, histological and genetic analysis of biomarkers or genes which are involved in the pathogenesis of COPD/Emphysema/Lungcancer.
Tidsramme: 0-1-3-6 years
|
All cases are prospectively collected in University hospital Leuven, Belgium.
Of enrolled subjects data are collected at 0,1,3 and 6 years interval
|
0-1-3-6 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Wim Janssens, MD. PhD., KU Leuven
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B32220072389
- S50623
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