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RecruitingNCT06097910Updated Jan 31, 2025

Surveillance for Multifocal GGNs

An observational study in Lung Ground-glass Opacities and Active Surveillance, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-31.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
370
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) with the identification number ECTOP-1021. The primary objective of the study is to assess the overall survival of patients with multifocal ground-glass opacities by employing a active surveillance approach rather than opting for surgical resection.

Read the detailed description

The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.

02

Conditions studied

  • Lung Ground-glass Opacities
  • Active Surveillance
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatients who are willing to particiapte in the study and meet the inclusion and exculsion criteria.

Eligibility criteria

Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria.

  1. Demonstrates the following on thin-section computed tomography (TSCT) scan:

    1. Presence of three or more GGNs (bilateral lesions are permitted).
    2. All lesions have remained stable without regression or enlargement for at least 3 months.
    3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter >=0.6cm and \<=2cm.
    4. CTR \<=0.25 in all lesions.
    5. No lymph node with a diameter >1cm in the mediastinal view.
    6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
  2. Aged 18-75 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Has not previously undergo any anti-tumor drug or radiation therapy.
  5. Written informed consent.

Exclusion criteria Patients will be excluded if they meet any of the following criteria.

  1. History of any prior malignancies within the past 5 years.
  2. History of lung surgery.
  3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
  4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
370 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Observation

    Procedure: Watchful waiting

Interventions

  • ProcedureWatchful waiting

    Conduct thoracic computed tomography scans every 12 months. The decision regarding surgery is based on the surgeon's evaluation of radiologic follow-up. The reference resection criteria encompass: a) Any lesion that progresses to a tumor diameter larger than 2cm or has CTR greater than 0.25. b) Clinical Tumor, node, metastasis (TNM) stage upstaging.

06

What researchers measure

Primary outcomes

  1. 5-year overall survival

    The event is defined as the death due to any causes.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Fudan University Cancer Center
    Shanghai, Shanghai 200032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The clinical data including patient characteristics and CT images.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06097910
Lead sponsor
Fudan University
Responsible party
Haiquan Chen (Director in the Department of Thoracic Surgery, FUSCC, Fudan University) — Principal investigator
First posted
Oct 24, 2023
Start date
Nov 1, 2023
Primary completion
Nov 1, 2036 (estimated)
Completion
Nov 1, 2036 (estimated)
Last update
Jan 31, 2025

Study contacts

Haoxuan Wu, Dr.
Contact
haoxuanwu@hotmail.com
86-021-64175590 ext. 63189

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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