Chest Imaging, Breath, and Biomarkers in a Screening Trial
17. mai 2017 oppdatert av: Moulay Meziane, MD, The Cleveland Clinic
A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial
The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment.
The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The fight against lung cancer is waged on three major fronts: prevention, detection and treatment.
Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT scan can detect disease earlier when treatment is more effective.
If we improve the detection of disease, we will see if screening reduces the incidence of symptomatic advanced lung cancer relative to no screening in people at high risk to develop lung cancer.
Studietype
Observasjonsmessig
Registrering (Faktiske)
1424
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Primary care physicians or any other physician may refer potential candidates.
Additionally, subjects may see marketing materials and contact the research team directly.
There is no restriction to the area of residence of subjects.
Beskrivelse
Inclusion Criteria:
- ages 40-75 years
If ages 40-59, then one of the following criteria needs to be met:
- Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR
- current or ex-smoker with > 25 pack years and COPD OR
- current or ex-smoker with a > 35 pack year history
If ages 60-75, then one of the following additional criteria needs to be met:
- Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR
- Current or ex-smoker with >25 pack years and COPD OR
- Current or ex-smoker with a >30 pack year history
- Subject is able to return to Cleveland Clinic for annual follow-up screening
- Subject is willing to sign a medical release form
Exclusion Criteria:
- Current health requires oxygen
- Have had a chest x-ray or CT of the chest within the last 6 months
- Previous pneumonectomy
- Lobectomy of the lung within the last 5 years
- Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer
- A medical condition that would prevent treatment for lung cancer
Within the last 6 weeks, one of the following has occured:
- A new cough or chronic cough that has gotten worse
- Either new shortness of breath, or any worsening of shortness of breath
- A cough producing blood
- Constant chest pain
- Respiratory infection, pneumonia, or cold
- Unintentional and unexplained weight loss greater than 5% of total body weight
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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all enrolled subjects
Intervention is chest x-ray and CT scan.
The chest x-ray image is read first without computer aided detection (CAD) and then a second time with computer aided detection (CAD) the CT scan is read by one reader.
Subjects are asked to contribute breath and blood samples.
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PA view, low dose CT scan
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The sensitivities of chest x-ray with CAD and chest CT
Tidsramme: One year after scan
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The false positive rates of chest x-ray with CAD and chest CT will be compared.
The analysis will be based on the study subjects from this prospective study who test positive with chest x-ray and/or CT and who are determined not to have lung cancer during the follow-up period.
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One year after scan
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Disease-specific mortality between screening with chest x-ray and CAD versus no screening
Tidsramme: One year after scan
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Mortality rate in screening x-ray vs CAD
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One year after scan
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All-cause mortality rate between screening with chest x-ray and CAD versus no screening
Tidsramme: One year after scan
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All cause mortality rate
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One year after scan
|
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Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls
Tidsramme: One year after scan
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Time between randomization and symptom
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One year after scan
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Does lung cancer screening with chest x-rays and computer aided detection (CAD) reduce the incidence of symptomatic advanced lung cancer in a high risk population
Tidsramme: One year after scan
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Cancer detection rate between chest x-ray and CAD
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One year after scan
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The quality of life between screening with chest x-ray and CAD versus no screening.
Tidsramme: One year after scan
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Quality of life between the chest x-ray group and the CAD group
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One year after scan
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Micheal Phillips, M.D., The Cleveland Clinic
- Hovedetterforsker: Moulay Meziane, MD, Chair of Thoracic Imaging
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Mazzone PJ, Obuchowski N, Fu AZ, Phillips M, Meziane M. Quality of life and healthcare use in a randomized controlled lung cancer screening study. Ann Am Thorac Soc. 2013 Aug;10(4):324-9. doi: 10.1513/AnnalsATS.201301-007OC.
- Mazzone PJ, Obuchowski N, Phillips M, Risius B, Bazerbashi B, Meziane M. Lung cancer screening with computer aided detection chest radiography: design and results of a randomized, controlled trial. PLoS One. 2013;8(3):e59650. doi: 10.1371/journal.pone.0059650. Epub 2013 Mar 20.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2008
Primær fullføring (Faktiske)
1. mai 2014
Studiet fullført (Faktiske)
1. mai 2014
Datoer for studieregistrering
Først innsendt
10. november 2008
Først innsendt som oppfylte QC-kriteriene
9. august 2012
Først lagt ut (Anslag)
13. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 07-455
- State of Ohio grant (Annet stipend/finansieringsnummer: 06-055)
- 06-055 (Annet stipend/finansieringsnummer: State of Ohio)
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