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This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate 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 | Active surveillance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active surveillance | Procedure | Conduct thoracic computed tomography scans every 12 months. If progression occurs, the treamtent approach would involve surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | The event is defined as the death due to any causes. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 10-year overall survival | The event is defined as the death due to any causes. | 10 years |
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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:
Has not previously undergo any anti-tumor drug or radiation therapy for the lung lesions.
Aged 18-75 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Written informed consent.
Patients will be excluded if they meet any of the following criteria.
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Outpatients visiting the hospitals/medical centers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China |
The clinical data including patient characteristics, CT images and pathology 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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