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
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.
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.
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.
Outpatients who are willing to particiapte in the study and meet the inclusion and exculsion criteria.
Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria.
Demonstrates the following on thin-section computed tomography (TSCT) scan:
Exclusion criteria Patients will be excluded if they meet any of the following criteria.
Procedure: Watchful 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.
5-year overall survival
The event is defined as the death due to any causes.
Time frame: 5 years
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.
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