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Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease

20. december 2011 opdateret af: University College, London

A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]

RATIONALE: Screening tests or exams may help doctors find lung cancer sooner, when it may be easier to treat.

PURPOSE: This randomized clinical trial is studying screening tests or exams to see how well they work compared to usual care in finding early stage lung cancer in current or past smokers with chronic obstructive pulmonary disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To show that the proportion of lung cancer diagnosed at stage I or II is significantly greater in the surveillance arm than in the control arm.

Secondary

  • Establish whether sputum cytology and/or cytometry can be employed to stratify patients with chronic obstructive pulmonary disease (COPD) according to their risk of developing incidence lung cancer.
  • Identify patients with pre-invasive lesions in their airways and examine the risk of developing lung cancer in patients harboring these lesions.
  • Provide an opportunity to archive blood samples from patients under surveillance to enable the identification of markers of disease progression.
  • Examine the compliance of regular screening among patients in this high-risk group.
  • Determine the proportion of patients in which it is not possible to provide a sputum screening result.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to recruiting site, age, gender, smoking history (current vs ex-smoker) and severity of chronic obstructive pulmonary disease (COPD) (mild vs moderate). Patients are randomized to 1 of 2 arms.

  • Control arm: Patients are managed according to the usual practice of their hospital or general practice for their COPD treatment. They undergo no particular investigations except those that may arise due to a change in their clinical condition. Those patients who are not diagnosed with lung cancer during the course of the study are offered a chest x-ray after 5 years of follow-up.
  • Surveillance arm: Patients undergo surveillance for 5 years. A sputum sample is collected for cytology and cytometry. If the sputum sample is normal the patient is asked to provide a sputum sample annually. If the sputum sample is abnormal the patient undergoes an annual spiral CT scan followed by autofluorescence bronchoscopy. At bronchoscopy, the following samples are taken: bronchial washings, bronchial brushings, and bronchial biopsies. Bronchoscopy is repeated every 4-12 months depending upon the histology results. If an invasive lesion is found, the patient is referred for treatment via the normal hospital systems. Any remaining sputum sample is stored frozen as part of the tissue bank associated with this trial.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1569

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • England
      • Cambridge, England, Det Forenede Kongerige, CB23 3RE
        • Papworth Hospital
      • Coventry, England, Det Forenede Kongerige, CV2 2DX
        • Walsgrave Hospital
      • Leeds, England, Det Forenede Kongerige, LS1 3EX
        • Leeds General Infirmary
      • Leicester, England, Det Forenede Kongerige, LE3 9QP
        • University Hospitals Of Leicester Nhs Trust
      • London, England, Det Forenede Kongerige, SW3 6NP
        • Royal Brompton Hospital
      • London, England, Det Forenede Kongerige, SW10 9NH
        • Chelsea Westminster Hospital
      • London, England, Det Forenede Kongerige, WC1E 5DB
        • University College Hospital - London
      • Manchester, England, Det Forenede Kongerige, M23 9LT
        • Wythenshawe Hospital
      • Sunderland, England, Det Forenede Kongerige, SR4 7TP
        • Sunderland Royal Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT9 7AB
        • Respiratory Research Office Belfast City Hospital

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Meets 1 of the following criteria:

    • Current smoker, defined as ≥ a 20 pack year smoking history and/or 20 year duration of smoking
    • Ex-smoker who has quit smoking within the past 8 years AND has ≥ a 20 pack year smoking history and/or 20 year duration of smoking

  • Mild to moderate chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria

    • Mild COPD: FEV_1/forced vital capacity (FVC) < 70%; FEV_1 ≥ 80% of predicted*
    • Moderate COPD: FEV_1/FVC < 70%; FEV_1 50-80% of predicted* NOTE: *Spirometric values will be obtained post bronchodilator according to the recommendations in the GOLD criteria

Exclusion criteria:

  • Inadequate lung function (FEV_1 < 50% of predicted after bronchodilator)

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Life expectancy must be at least 5 years

Exclusion criteria:

  • History of malignant disease within the past 5 years except non-melanomatous skin cancers
  • Other serious co-morbidity
  • Evidence of severe or uncontrolled systemic diseases that, in the view of the investigator, makes it undesirable for the patient to participate in this trial
  • Any disorder making reliable informed consent impossible
  • Unlikely to co-operate with a 5 year follow-up

PRIOR CONCURRENT THERAPY:

  • Patients may receive all concurrent therapy deemed to provide adequate care as decided by their medical doctors

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Styring
Kontrolarm
Andet: Chest x ray
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years. This could help identify a lung cancer that may not have been associated with symptoms earlier.
Andet: Surveillance
Screened arm
Andet: cytology and cytometry specimen collection procedure
Samples tested and further interventions added if positive
Andet: Chest x ray
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years. This could help identify a lung cancer that may not have been associated with symptoms earlier.
Procedure: Autofluorescence bronchoscopy
The bronchial tree will be inspected first under white light and then under blue light. All areas that appear abnormal will initially be documented and only sampled when the bronchoscopic examination has been completed.
Andre navne:
  • AFB
Procedure: CT scan
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of lung cancer that is diagnosed as stage I or II
Tidsramme: 5 years
In the control arm, it is expected that only 15% of cancers will be detected early. In the surveillance arm, we expect that at the time of the first screen, the detection rate of prevalence cancers will be about 3%, from data reported in CT screening studies
5 years

Sekundære resultatmål

Resultatmål
Tidsramme
Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)
Tidsramme: 5 Years
5 Years
Proportion of patients in the surveillance arm who have abnormal sputum cytology
Tidsramme: 5 Years
5 Years
Proportion of patients in the surveillance arm who have abnormal sputum cytometry
Tidsramme: 5 Years
5 Years
Death from lung cancer
Tidsramme: Up to 15 years
Up to 15 years
Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples)
Tidsramme: 5 Years
5 Years
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
Tidsramme: 5 Years
5 Years
Number of patients in the surveillance arm with pre-invasive lesions who develop lung cancer locally and at remote sites within the lung
Tidsramme: 5 Years
5 Years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University College, London

Efterforskere

  • Studiestol: Stephen G. Spiro, University College London Hospitals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. august 2007

Primær færdiggørelse (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

6. august 2007

Først indsendt, der opfyldte QC-kriterier

6. august 2007

Først opslået (Skøn)

8. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. december 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. december 2011

Sidst verificeret

1. december 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000558413
  • CRUK-BRD/06/10
  • EU-20738
  • ISRCTN80745975

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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