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Early Detection of Lung Cancer With Low-dose Multislice Computed Tomography

27 de febrero de 2020 actualizado por: National Taiwan University Hospital

Early Detection of Lung Cancer With Low-dose Multislice Computed Tomography (LDCT)- a Screening Program

Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought to be the best screening tool for lung cancer. However, there is growing concerns about radiation exposure, high cost, and high rate of false-positive screening result. Epidemiologic studies from western countries showed that cigarette smoking is the major cause of lung cancer, and other risk factors may include age, environmental pollution, occupational exposures (included of radon exposure), gender, race, and pre-existing lung diseases. Adenocarcinoma is the major type of lung cancer in Taiwan and is less attributable to smoking. The investigators need a different risk prediction model adapted to the investigators country.

National Taiwan University Hospital Chu-Tung Branch initiated the lung cancer screening by LDCT since June 2015. Many people can get the LDCT screening with affordable price with the subsidy from enterprise donation. The purpose of this study is observing those participants with 2-year follow-up. Furthermore, those data may connect with another study of "Low dose computed tomography screening study in nonsmoker with risk factors for lung cancer in Taiwan" (Non-smoker study)which is implemented in other hospitals in Taiwan.For reality limiting, After one year, the enrollment rate was a lot lower than expected. We extended the enrollment time but only observe those participants for one year not two year..

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought to be the best screening tool for lung cancer. However, there is growing concerns about radiation exposure, high cost, and high rate of false-positive screening result. Epidemiologic studies from western countries showed that cigarette smoking is the major cause of lung cancer, and other risk factors may include age, environmental pollution, occupational exposures (included of radon exposure), gender, race, and pre-existing lung diseases. Adenocarcinoma is the major type of lung cancer in Taiwan and is less attributable to smoking. The investigators need a different risk prediction model adapted to the investigators country.

National Taiwan University Hospital Chu-Tung Branch initiated the lung cancer screening by LDCT since June 2015. Many people can get the LDCT screening with affordable price with the subsidy from enterprise donation. The purpose of this study is observing those participants with 2-year follow-up. Furthermore, those data may connect with another study of "Low dose computed tomography screening study in nonsmoker with risk factors for lung cancer in Taiwan" (Non-smoker study)which is implemented in other hospitals in Taiwan.

Aim 1: Being the control group of the non-smoker study, the investigators collect the relevant information from participants to validate and modify their risk assessment model. Applying the same the questionnaires of the non-smoker study and results of LDCT screening in different population. All data could provide extra information to improve their risk prediction model for predicting lung cancer in non-smokers in Taiwan.

Aim 2: To establish the local epidemiological data for lung pathology. From the baseline data, screening results of LDCT, telephone follow up on questionable lesions, collection of patient's medical records, and linkage to National Health Insurance Database, the investigators will be able to establish local epidemiology data on lung pathology as well as information on screening accuracy of LDCT.

Aim 3: To examine the psychosocial impacts and health behaviors of the participants receiving LDCT. Questionnaire surveys provide the understanding of anxiety and life quality at several time points since LDCT screening. The study was to investigate whether the screening results were associated with health behaviors change, such as smoking, drinking, and exercise.

With low enrollment rate in first year, we decided to extend the enrollment period. But we only observed those participants for one year, not 2 year. So far we carry on the analysis and the discussion.

Keywords: Lung cancer, Low dose computed tomography, screening, health behavior, psychological factors.

Tipo de estudio

De observación

Inscripción (Actual)

1334

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

20 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patients received LDCT screening at NTUH Chu-Tung Branch

Descripción

Inclusion Criteria:

  • age>=20
  • self pay the LDCT in National Taiwan University Hospital Chu-Tung Branch
  • ability to understand the informed consent form for complete the questionnaires
  • be willing and able to accept telephone access at the time scheduled

Exclusion Criteria:

NA

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Abnormal ct finding detection rate
Periodo de tiempo: 1-month
Abnormal ct finding detection rate is defined as number of abnormal ct finding/total enroll number
1-month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Chinese 14-item Perceived Stress Scale (Chinese 14-item PSS) score
Periodo de tiempo: 6-month
Stress will be measured using the Chinese 14-item Perceived Stress Scale (Chinese 14-item PSS) at baseline and 6 month follow-up.
6-month
Change in Chinese Health Questionnaire-12 (CHQ-12) score
Periodo de tiempo: 12-month
Psychological morbidity will be measured using the Chinese Health Questionnaire (CHQ-12) at baseline and 12 month follow-up.
12-month

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Ding-Cheng Chan, MD, PhD, National Taiwan University Hospital Chu-Tung Branch

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 febrero de 2016

Finalización primaria (Actual)

1 de mayo de 2017

Finalización del estudio (Actual)

1 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

10 de abril de 2016

Primero enviado que cumplió con los criterios de control de calidad

25 de abril de 2016

Publicado por primera vez (Estimar)

28 de abril de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de febrero de 2020

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

27 de febrero de 2020

Última verificación

1 de febrero de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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