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

20 de dezembro de 2011 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

1569

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Triagem
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Ao controle
Braço de controle
Outro: 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.
Outro: Surveillance
Screened arm
Outro: cytology and cytometry specimen collection procedure
Samples tested and further interventions added if positive
Outro: 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.
Procedimento: 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.
Outros nomes:
  • AFB
Procedimento: CT scan
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of lung cancer that is diagnosed as stage I or II
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Prazo
Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)
Prazo: 5 Years
5 Years
Proportion of patients in the surveillance arm who have abnormal sputum cytology
Prazo: 5 Years
5 Years
Proportion of patients in the surveillance arm who have abnormal sputum cytometry
Prazo: 5 Years
5 Years
Death from lung cancer
Prazo: 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)
Prazo: 5 Years
5 Years
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
Prazo: 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
Prazo: 5 Years
5 Years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University College, London

Investigadores

  • Cadeira de estudo: Stephen G. Spiro, University College London Hospitals

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2007

Conclusão Primária (Real)

1 de março de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

6 de agosto de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de agosto de 2007

Primeira postagem (Estimativa)

8 de agosto de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

21 de dezembro de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de dezembro de 2011

Última verificação

1 de dezembro de 2011

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

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