RecruitingNot Applicable

Surveillance for Multifocal GGNs

China370 participantsStarted 2023-11-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Demonstrates the following on thin-section computed tomography (TSCT) scan:
✓. Presence of three or more GGNs (bilateral lesions are permitted).
✓. All lesions have remained stable without regression or enlargement for at least 3 months.
✓. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter \>=0.6cm and \<=2cm.
✓. CTR \<=0.25 in all lesions.
✓. No lymph node with a diameter \>1cm in the mediastinal view.
✓. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
✓. Aged 18-75 years.

Exclusion criteria

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

What they're measuring

5-year overall survival

Timeframe: 5 years

Trial details

NCT IDNCT06097910

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2036-11-01

Contact for this trial

Haoxuan Wu, Dr.

86-021-64175590 haoxuanwu@hotmail.com

View on ClinicalTrials.gov More Lung Ground-glass Opacities trials