Methods of Computed Tomography Screening and Management of Lung Cancer

NCT03992833 | Unknown DMC

• 1 other identifier: 2016YFE0103000
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasms; Computed Tomography; Mass Screening; Lung Nodules

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

lung cancer screening

EXPERIMENTAL

Participants will undergo a chest CT scan in the Department of Radiology at Tianjin Cancer Hospital. All scans will be performed using the same CT system: Definition AS. Two readings of the images will be performed. In the first image reading, the CT images will be read by specially trained Chinese resident radiologist and checked by one of two senior Chinese radiologists. Lung Cancer Screening (version 2. 2018) Guidelines of the National Comprehensive Cancer Network (NCCN) will be used for the management of lung nodules. This guideline recommends management of lung nodules based on diameter. In the second reading, a semi-automated volumetry software will be used to measure the volume and evaluate the other parameters of lung nodules. At baseline and one year after baseline, data about general characteristics, risk factors of lung cancer, and health status of the participants will be collected.

Other: lung cancer screening

Interventions

lung cancer screening OTHER

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).

lung cancer screening

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant woman will be excluded.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• University Medical Center Groningen: collaborator
• Shanghai Changzheng Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Tianjin Medical University Cancer Institute And Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhaoxiang Ye, Professor

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoxiang Ye, Professor

CONTACT

+8622-23340123; yezhaoxiang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: May 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2022
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

CN (1)