GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?
16. august 2021 opdateret af: Fundación para la Investigación del Hospital Clínico de Valencia
GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD Screening?
This is a multicenter observational prospective study in smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years / pack) with respiratory symptoms and presenting a normal spirometry.
The patients who sign the corresponding informed consent, will undergo a DLCO and will be divided into two groups according to the result:
- Group I. Patients with DLCO <80%.
- Group II Patients with DLCO≥80%.
Both groups will be followed for 5 years.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Forventet)
236
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Cruz González, PhD
- Telefonnummer: 0034961973677
- E-mail: cruz.gonzalez@uv.es
Studiesteder
-
-
Valencian Community
-
Valencia, Valencian Community, Spanien, 46010
- Hospital Clinico Universitario de Valencia
-
Kontakt:
- cruz Gonzalez, PhD
- Telefonnummer: 0034961973977
- E-mail: cruz.gonzalez@uv.es
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Subjects over 18 smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years /pack) with respiratory symptoms presenting normal spirometry
Beskrivelse
Inclusion Criteria:
- Age ≥18 years. The participant or his / her legal representative is willing and able to give informed consent to participate in the study.
- Female or male patients with age equal to or greater than 18 years.
- Smokers or ex-smokers with cumulative exposure ≥ 10 a / p
- Respiratory symptoms
- Normal spirometry.
Exclusion Criteria:
- Age under 18 years.
- Participation in another clinical study.
- Patients with a life expectancy of less than 2 years due to neoplasms or other serious systemic diseases.
- Refusal to sing informed consent.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Group I. Patients with DLCO <80%.
Patients with DLCO <80% will be followed at baseline and once a year during the study
|
Patients will followed during 5 years, Annual follo-up visits will be carried out during this period
|
|
Group II. Patients with DLCO ≥ 80%.
Patients with DLCO ≥80% only will be followed at baseline and year 5.
|
Patients will followed during 5 years, and only 2 visits , baseline and 5 years
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes from baseline of Diffusion Capacity (DLCO) at 5 years
Tidsramme: through study completion, an average of 5 years
|
To determine the value of DLCO in COPD screening in smokers and ex-smokers with respiratory symptoms and normal spirometry (GOLD 0)
|
through study completion, an average of 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk factors associated to the development of COPD
Tidsramme: through study completion, an average of 5 years
|
Risk factors associated to the development of COPD
|
through study completion, an average of 5 years
|
|
Changes from baseline of inflammatory Markers at 2 and 5 years
Tidsramme: 2 and 5 years
|
To Study soluble receptors involved in inflammation processes and tissue repair in early disease stages.
|
2 and 5 years
|
|
Oxidative stress
Tidsramme: through study completion, an average of 5 years
|
To Study of oxidative stress parameters in early disease stages
|
through study completion, an average of 5 years
|
|
Diffusion study
Tidsramme: through study completion, an average of 5 years
|
To Characterize patients in stage 0 of GOLD with impaired diffusion
|
through study completion, an average of 5 years
|
|
Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years
Tidsramme: Baseline and 5 years
|
To determine changes in HRCT to identify subgroups of patients with different clinical and evolutionary trajectories
|
Baseline and 5 years
|
|
Airflow limitation Study
Tidsramme: through study completion, an average of 5 years
|
To Investigate the contribution of measuring lung volumes for the diagnosis of COPD when there is no evidence of airflow limitation in spirometry (GOLD 0).
|
through study completion, an average of 5 years
|
|
Gender differences in value of diffusion (DLCO)
Tidsramme: through study completion, an average of 5 years
|
To assess if there are differences between men and women with diffusion disorder
|
through study completion, an average of 5 years
|
|
Childhood background
Tidsramme: Baseline
|
To assess whether factors, such as the effect of lung development during childhood and adolescence, bronchial hyperreactivity and / or the role of infections influences the risk of developing the disease or its progression.
|
Baseline
|
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Comorbidity
Tidsramme: through study completion, an average of 5 years
|
To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.
|
through study completion, an average of 5 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Cruz González, PhD, Hospital Clinico Universitario de Valencia
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
10. september 2021
Primær færdiggørelse (Forventet)
10. februar 2025
Studieafslutning (Forventet)
31. december 2025
Datoer for studieregistrering
Først indsendt
26. juli 2021
Først indsendt, der opfyldte QC-kriterier
16. august 2021
Først opslået (Faktiske)
23. august 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. august 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GOLD 0-DLCO 1
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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