A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules

The purpose of this study is to actively monitor patients with multiple pulmonary Ground-glass Nodules (GGNs), in order to provide evidence for multiple GGNs treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Pulmonary Nodules

Detailed Description

Multiple pulmonary GGNs are very commonly identified particularly as increasing numbers of CT scans are performed as part of routine lung cancer screening. At the same time, the ideal solution for these cases continues to be debated. This aim of this study is to learn more about the effects of multiple factors on outcome of multiple pulmonary GGNs, such as patients' clinical characteristics, CT features and different pathological types. Furthermore, the optimal timing of surgery and the effect of different surgical choices on the prognosis of patients with multiple GGNs will be investigated.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with multiple GGNs by chest CT scan in a hospital.

Description

Inclusion Criteria:

1. Age greater than 18 years
2. Have two or more GGNs on CT imaging
3. Diameter of GGNs > 5mm and ≤ 3cm
4. GGNs must be greater than half ground glass

Exclusion Criteria:

1. patients who have a history of lung cancer
2. patients who have undergone chemotherapy, radiotherapy or targeted therapy before surgery
3. pregnant women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year overall survival [Time Frame: From date of the recruitment, assessed up to 60 months]	5-year overall survival	October 31, 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year Progression-Free-Survival [Time Frame: From date of the recruitment, assessed up to 60 months]	5-year Progression-Free-Survival	October 31, 2024
Recurrence-free survival [Time Frame: From date of the recruitment, assessed up to 60 months]	Recurrence-free survival	October 31, 2024

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 31, 2019
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Lung Neoplasms; Multiple Pulmonary Nodules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: TJ-LC-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No