Clinical trial · Observational
Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1015)
Concordance Between Intraoperative Frozen Section Pathology and Postoperative Paraffin-embedded Pathology in Diagnosing the IASLC Grade of Lung Adenocarcinoma
NCT05794711CI-TRIAL-00068230unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pathology | — | UNRESOLVED | — |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery.
- interventionNames
- Procedure: Surgical resection
Primary outcomes (1)
- measure
- Concordance rate
- timeFrame
- 2 years
- description
- Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of IASLC grades of lung adenocarcinoma
Secondary outcomes (5)
- measure
- Concordance rate
- timeFrame
- 2 years
- description
- Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of lung adenocarcinoma subtypes according to the WHO classifications.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients who sign the informed consent form and are willing to complete the study according to the study protocol; * No previous history of cancer or pulmonary surgery; * Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan; * Peripheral clinical T1N0M0 patients that are eligible for surgery; * Non-small cell lung cancer is pathologically diagnosed before or at surgery; * No radiation therapy or chemotherapy before surgery. Exclusion Criteria: * Patients with clinical stages other than T1N0M0; * The lesion cannot be completely resected; * Previous history of cancer; * Patients having received radiation therapy or chemotherapy.
References
Publications (1)
- DERIVEDFu 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. PMID 38781043