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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Watchful waiting | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | The event is defined as the death due to any causes. | 5 years |
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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:
Aged 18-75 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has not previously undergo any anti-tumor drug or radiation therapy.
Written informed consent.
Exclusion criteria Patients will be excluded if they meet any of the following criteria.
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Outpatients who are willing to particiapte in the study and meet the inclusion and exculsion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haoxuan Wu, Dr. | Contact | 86-021-64175590 | 63189 | haoxuanwu@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40983284 | Derived | Wu H, Fu F, Ye T, Hu H, Yu Q, Zhang H, Jiang F, Song Q, Ma J, Hei T, Cheng Y, Gong M, Wang S, Gu Y, Li Y, Wu W, Zhang Y, Chen H. Active Surveillance of Multifocal Ground-Glass Opacities: Results of a Prospective Multicenter Trial (ECTOP1021). J Thorac Oncol. 2026 Jan;21(1):150-159. doi: 10.1016/j.jtho.2025.09.011. Epub 2025 Sep 20. | |
| 40400915 |
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The clinical data including patient characteristics and CT images.
Within five years from the study end.
Medical oncologists and surgeons who are interested in the study. Emails could be sent to the address below to obtain the shared data:
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Wu H, Deng P, Fu F, Zhang Y, Chen H. Active surveillance for patients with multifocal ground-glass nodules: protocol of a prospective, multi-center, single-arm trial (ECTOP-1021). J Thorac Dis. 2025 Apr 30;17(4):2634-2639. doi: 10.21037/jtd-2024-1956. Epub 2025 Apr 28. |