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Trial record 18 of 87 for:    lung cancer AND risk factors

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

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ClinicalTrials.gov Identifier: NCT02754388
Recruitment Status : Enrolling by invitation
First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease
Lung Cancer

Detailed Description:

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.

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


Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Target Follow-Up Duration: 98 Weeks
Official Title: Early Detection of Lung Cancer With Low-dose Multislice Computed Tomography (LDCT)- a Screening Program
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Abnormal ct finding detection rate [ Time Frame: 1-month ]
    Abnormal ct finding detection rate is defined as number of abnormal ct finding/total enroll number


Secondary Outcome Measures :
  1. Change in Chinese 14-item Perceived Stress Scale (Chinese 14-item PSS) score [ Time Frame: 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.

  2. Change in Chinese Health Questionnaire-12 (CHQ-12) score [ Time Frame: 12-month ]
    Psychological morbidity will be measured using the Chinese Health Questionnaire (CHQ-12) at baseline and 12 month follow-up.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients received LDCT screening at NTUH Chu-Tung Branch
Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754388


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ding-Cheng Chan, MD, PhD National Taiwan University Hospital Chu-Tung Branch
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02754388     History of Changes
Other Study ID Numbers: 201512060RIND
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Taiwan University Hospital:
LDCT, screening, health behavior, psychological factors

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases