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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03992833
Other study ID # 2016YFE0103000
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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