Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06097910

Surveillance for Multifocal GGNs

Led by Fudan University · Updated on 2025-01-31

370

Participants Needed

1

Research Sites

678 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Surveillance for Multifocal GGNs

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of three or more ground-glass nodules on thin-section CT scan, including bilateral lesions
  • Nodules have been stable without regression or enlargement for at least 3 months
  • Dominant nodule size between 0.6 cm and 2 cm in maximum diameter
  • Consolidation-to-tumor ratio (CTR) of 0.25 or less in all nodules
  • No lymph node enlargement over 1 cm in mediastinal view
  • Dominant lesion not adjacent to pleura and no pleural retraction signs
  • Age between 18 and 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • No prior anti-tumor drug or radiation therapy
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • History of any cancer within the past 5 years
  • Prior lung surgery
  • History of interstitial pneumonia, pulmonary fibrosis, or other severe lung diseases
  • Severe or uncontrolled diseases that may reduce life expectancy to less than 10 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fudan University Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

H

Haoxuan Wu, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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