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Methods of Computed Tomography Screening and Management of Lung Cancer

NCT03992833 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2019-06-20

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Shanghai Changzheng Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Zhaoxiang Ye, Professor · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-05-31
Completion
2022-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03992833 on ClinicalTrials.gov