Methods of Computed Tomography Screening and Management of Lung Cancer

Lung Neoplasms Clinical Trial

Official title:

Methods of Computed Tomography Screening and Management of Lung Cancer in Tianjin: A Population-based Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03992833
• Other study ID #: 2016YFE0103000
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: September 2022

Study information

• Verified date: June 2019
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Zhaoxiang Ye, Professor
• Phone: +8622-23340123
• Email: yezhaoxiang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

European lung cancer screening studies using computed tomography (CT) have shown that a management protocol based on measuring lung nodule volume and volume doubling time (VDT) is more specific for early lung cancer detection than a diameter-based protocol. However, whether this also applies to a Chinese population is unclear. The aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a Chinese population.

Description:

In this population-based study, participants will undergo a low-dose chest CT scan for two rounds. At baseline, the first CT scan will be performed in all participants and their data will be collected. One-year after the baseline, a second CT scan will be performed and data will be collected again. CT images of each participant will be read twice independently by two groups of readers after the baseline and 1-year follow-up scans. In the first reading, the detected lung nodules are evaluated for diameter and managed according to a routine diameter-based protocol. The clinical management of participants are based on the first reading. In the second reading, each scan will be interpreted again by radiologists, blinded to the first reading. Semi-automated volumetry software will be used. The lung nodules will be evaluated for volume and management will be simulated according to a European volume-based protocol. Participants will be followed up and any diagnosis of lung cancer and related information will be collected at the fourth year through the hospital information system and by contacting the participants or their relatives.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: September 2022
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

Inclusion Criteria:

• Aged 40-74 years;

• Resident in the Hexi district of Tianjin city for at least 3 years;

• Having no self-reported history of any malignant tumor.

Exclusion Criteria:

• Pregnant woman will be excluded.

Related Conditions & MeSH terms

• Computed Tomography
• Lung Neoplasms
• Lung Nodules
• Mass Screening

Intervention

Other:
• lung cancer screening
In the first reading, according to the NCCN lung cancer screening guideline, participants with a solid nodule= 5 mm in diameter will be referred to undergo follow-up CT 1 year after the baseline. Participants with a solid nodule 6-14 mm will be referred to undergo follow-up thorax CT 3-6 months after the baseline. Participants with a solid nodule = 15 mm will be referred to a multidisciplinary team for clinical investigation. The simulated management will be based on the volume of lung nodule and volume doubling time from the second reading, lung nodules will be reclassified according to the reference values from the European volume-based lung nodule management protocol. According to the European volume-based protocol, the solid and part-solid lung nodules will be reclassified into three groups: nodules with a volume < 100 mm3 (negative), nodules with a volume of 100-300 mm3 (indeterminate), and nodules with a volume > 300 mm3 (positive).

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute And Hospital	Tianjin	Tianjin

Sponsors (4)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Shanghai Changzheng Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, University Medical Center Groningen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of clinically diagnosed lung cancer	The number of clinically diagnosed lung cancer will be collected through the hospital information system and by contacting the participants or their relatives using a questionnaire.	at the fourth year from baseline
Primary	number of lung cancer death	The number of lung cancer death will be collected through the hospital information system and by contacting the relatives of the participants using a questionnaire.	at the fourth year from baseline