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

27 février 2020 mis à jour par: 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..

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

1334

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients received LDCT screening at NTUH Chu-Tung Branch

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Abnormal ct finding detection rate
Délai: 1-month
Abnormal ct finding detection rate is defined as number of abnormal ct finding/total enroll number
1-month

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Chinese 14-item Perceived Stress Scale (Chinese 14-item PSS) score
Délai: 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
Délai: 12-month
Psychological morbidity will be measured using the Chinese Health Questionnaire (CHQ-12) at baseline and 12 month follow-up.
12-month

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2016

Achèvement primaire (Réel)

1 mai 2017

Achèvement de l'étude (Réel)

1 décembre 2019

Dates d'inscription aux études

Première soumission

10 avril 2016

Première soumission répondant aux critères de contrôle qualité

25 avril 2016

Première publication (Estimation)

28 avril 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 février 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 février 2020

Dernière vérification

1 février 2020

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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