- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01663155
Chest Imaging, Breath, and Biomarkers in a Screening Trial
17 maj 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
1424
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The sensitivities of chest x-ray with CAD and chest CT
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Disease-specific mortality between screening with chest x-ray and CAD versus no screening
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Micheal Phillips, M.D., The Cleveland Clinic
- Huvudutredare: Moulay Meziane, MD, Chair of Thoracic Imaging
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2008
Primärt slutförande (Faktisk)
1 maj 2014
Avslutad studie (Faktisk)
1 maj 2014
Studieregistreringsdatum
Först inskickad
10 november 2008
Först inskickad som uppfyllde QC-kriterierna
9 augusti 2012
Första postat (Uppskatta)
13 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 07-455
- State of Ohio grant (Annat bidrag/finansieringsnummer: 06-055)
- 06-055 (Annat bidrag/finansieringsnummer: State of Ohio)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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