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Not yet recruiting NCT06768853

The Accuracy of Targeted Lymph Node Dissection of Non-small Cell Lung Cancer Patients According to Predictive Models

No phase Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lymph node dissection based on the guidelines, Lymph node dissection based on the model.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Study on Predicting Mediastinal Lymph Node Metastasis in Patients with Lung Cancer by the Predictive Model Based on Clinical Characteristics and Radiomics

Overview

Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.

Detailed description

Investigators combined the clinical and radiomics characteristics of resectable non-small cell lung cancer patients to construct an accurate model for preoperative prediction of mediastinal lymph node status. Investigators will randomly divide all enrolled patients into an experimental group and a control group. For the patients in the experimental group, lymph nodes will be dissected based on the predicted lymph node status by the model, while in the control group, the lymph nodes will be dissected according to the NCCN guidelines (2023). Investigators will calculate the consistency between preoperative prediction results and postoperative pathological results to verify the accuracy of the model. And investigators will evaluate the impact of this new lymph node dissection method on prognosis by comparing the intraoperative blood loss, postoperative complications, disease-free survival, and overall survival between the two groups of patients. Investigators expect that performing lymph node dissection according to the predictive model can lead to better prognosis for patients.

Interventions

  • Procedure Lymph node dissection based on the guidelines
    During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .
  • Procedure Lymph node dissection based on the model
    During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.

Primary outcome measures

  • Consistency rate between preoperative prediction results and postoperative pathological results [Time frame: 1 week after surgery]
Secondary outcome measures (7)
  • Postoperative complications [Time frame: 30 days after surgery]
  • Postoperative recurrence rate [Time frame: 2 years after surgery]
  • Disease-free survival [Time frame: 2 years after surgery]
  • Overall survival [Time frame: 2 years after surgery]
  • Intraoperative blood loss [Time frame: During the surgery]
  • Postoperative drainage volume [Time frame: 2 weeks after surgery]
  • Postoperative drainage time [Time frame: 2 weeks after surgery]

Eligibility criteria

Inclusion criteria

  • Age range from 18 to 70 years old;
  • Chest CT shows a single pulmonary nodule, which may be adenocarcinoma or squamous cell carcinoma;
  • Chest CT shows multiple pulmonary nodules, but preoperative evaluation suggests that pulmonary nodules other than the main lesion are benign;
  • Preoperative auxiliary examination evaluates the patient as clinically resectable lung adenocarcinoma or squamous cell carcinoma in stages I, II, or IIIA (UICC-TNM 9th edition);
  • ECOG score 0-1;
  • Preoperative lung function FEV1 ≥ 1.0L and actual/expected value ≥ 80%;
  • No contraindications for surgery;
  • Technically, lobectomy or segmental resection combined with lymph node dissection can be performed;
  • Preoperative plain scan and enhanced chest CT examination;
  • The interval between surgery and chest CT, lung function, and electrocardiogram examinations is less than or equal to 28 days;
  • The patient signs a written informed consent form.

Exclusion criteria

  • Chest CT suggests multiple primary lung cancer or metastatic cancer;
  • Previous history of thoracic surgery;
  • Previous history of malignant tumors;
  • History of neoadjuvant therapy;
  • A history of severe heart failure, myocardial infarction, cerebral infarction, and pneumonia within 6 months prior to surgery;
  • Concurrent active bacterial or fungal infections;
  • Severe underlying lung diseases such as interstitial lung disease, pulmonary fibrosis, or emphysema are complicated;
  • Concomitant mental illness;
  • Pregnant/lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Zhongnan Hospital of Wuhan University — Wuhan

Identifiers

NCT: NCT06768853 · 20240329

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗