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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Immunotherapy | Establishment of a neoadjuvant ICI treatment cohort for resectable stage II-III lung cancer patients and acquisition of clinical-pathological-radiological data |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathologic response after surgery, assessed according to IASLC pathologic response criteria, including major pathologic response and pathologic complete response in resected specimens following neoadjuvant CIT. | Pathologic response after surgery will be assessed according to the IASLC pathologic response criteria in resected tumor specimens following neoadjuvant CIT. Pathologic Complete Response (pCR): No residual viable tumor cells (0% viable tumor). Major Pathologic Response (MPR): ≤10% residual viable tumor cells. Evaluation Method: Pathologic response will be determined by histopathological examination of the resected tumor tissue, with tumor regression grading based on hematoxylin and eosin (H&E) staining. | Within the first 30 days (plus or minus 3 days) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months. Recurrence was defined as a diagnosis of metastatic disease, new locoregional disease, or any additional treatments for NSCLC after a 90-day treatment-free interval (to indicate the end of primary treatment and serve as a proxy for disease-free state postsurgery) starting right after initial surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who visited the Severance Hospital Lung Cancer Center Outpatient Clinic (Thoracic Surgery and Hematology Oncology) where the research team is affiliated will be registered after reviewing whether they meet the above selection/exclusion criteria by a researcher assigned by the research director.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae Hee Hong | Contact | (82)10-3487-6255 | thhongcs@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine | Recruiting | Seoul | South Korea |
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·Before Neoadjuvant ICI treatment; 1) whole blood 20ml 2) Paraffin specimen from needle biopsy or bronchoscopy biopsy performed at the time of initial diagnosis and staging ·After Neoadjuvant ICI treatment 1) whole blood 20ml 2) One piece of tumor tissue sample (fresh tissue, 1cm x 1cm) scheduled to be discarded after surgery is collected on the day of surgery.
| Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months |