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This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1015). The goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (cT1N0M0) lung adenocarcinomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical resection | Procedure | Surgical resection of lung adenocarcinoma. Wedge resection, segmentectomy or lobectomy will be performed according to each patients' condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concordance rate | Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of IASLC grades of lung adenocarcinoma | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance rate | Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of lung adenocarcinoma subtypes according to the WHO classifications. | 2 years |
| Concordance rate |
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Inclusion Criteria:
Exclusion Criteria:
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Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical resection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Zhao, M.D., Ph.D. | Contact | +86 18801735510 | yuezhao97@outlook.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 |
|---|---|---|---|
| 38781043 | Derived | Fu Z, Shen X, Deng C, Cao H, Jin Y, Zheng Q, Yang Y, Qian B, Yuan C, Wang W, Zhang L, Song Q, Zuo S, Ma J, You S, Zheng S, Gao Q, Su G, Zhang Y, Fu F, Chen H, Li Y. Prediction of the pathological subtypes by intraoperative frozen section for patients with cT1N0M0 invasive lung adenocarcinoma (ECTOP-1015): a prospective multicenter study. Int J Surg. 2024 Sep 1;110(9):5444-5451. doi: 10.1097/JS9.0000000000001667. |
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| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of pleural invasion and lymph node invasion.
| 2 years |
| Concordance rate | Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of spread through air space (STAS). | 2 years |
| Recurrence-free survival (RFS) | Recurrence-free survival (RFS) is defined as the time from date of curative surgery to the time of recurrence or death, whichever comes first. | 5 years |
| Overall survival (OS) | Overall survival (OS) is defined as the time from date of curative surgery to the time of death of any reason. | 5 years |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |