Clinical trial · Observational
Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer
Risk Factors of Medistinal Metastasis in Endoscopic Medistinal Staging of Non-small Cell Lung Cancer
- 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)
The purpose of this study is to investigate risk factors for mediastinal lymph node metastasis in potentially operable non-small cell lung cancer in order to find indications for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging. CT and PET/CT findings, histologic types and other risk factors will be analyzed. The investigators develop the prediction method for mediastinal metastasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Relative risk of risk factors for mediastinal metastasis
- timeFrame
- When confirmative diagnosis are available in all subjects ;3 years
- description
- risk factors; CT staging (N0-3), PET staging (N0-3), tumor location(central or peripheral), tumor size and histologic types of lung cancer.
Secondary outcomes (3)
- measure
- Diagnostic values of endoscopic staging
- timeFrame
- When confirmative diagnosis are available in all subjects ;3 years
- description
- sensitivity, negative predictive value, accuracy
- measure
- Survival
- timeFrame
- After the diagnosis ; 7 years
- description
- survival after lung cancer treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC) * Potentially operable Exclusion Criteria: * M1 disease * Inoperable T4 disease * Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT * Confirmed supraclavicular lymph node metastasis * Pancoast tumours * T1 ground glass opacity nodule (with solid part 1\<cm) * Solid T1 (1\<cm)N0 M0 by CT \& PET/CT * Inoperable patients (after evaluating medical and surgical operability) * Patients who refused surgical treatment * Contraindications for bronchoscopy * Drug reaction to lidocaine, midazolam, fentanyl * Pregnancy
References
Publications (1)
- DERIVEDChung HS, Yoon HI, Hwangbo B, Park EY, Choi CM, Park YS, Lee K, Ji W, Park S, Lee GK, Kim TS, Kim HY, Kim MS, Lee JM. Prediction Models for Mediastinal Metastasis and Its Detection by Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration in Potentially Operable Non-Small Cell Lung Cancer: A Prospective Study. Chest. 2023 Sep;164(3):770-784. doi: 10.1016/j.chest.2023.03.041. Epub 2023 Apr 3. PMID 37019355