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

20 de diciembre de 2011 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

1569

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Control
Brazo de control
Otro: 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.
Otro: Surveillance
Screened arm
Otro: cytology and cytometry specimen collection procedure
Samples tested and further interventions added if positive
Otro: 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.
Procedimiento: 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.
Otros nombres:
  • AFB
Procedimiento: CT scan
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of lung cancer that is diagnosed as stage I or II
Periodo de tiempo: 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 resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University College, London

Investigadores

  • Silla de estudio: Stephen G. Spiro, University College London Hospitals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2007

Finalización primaria (Actual)

1 de marzo de 2011

Fechas de registro del estudio

Enviado por primera vez

6 de agosto de 2007

Primero enviado que cumplió con los criterios de control de calidad

6 de agosto de 2007

Publicado por primera vez (Estimar)

8 de agosto de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de diciembre de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

20 de diciembre de 2011

Última verificación

1 de diciembre de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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