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

NCT06768853 | Not Yet Recruiting

• 1 other identifier: 20240329
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer; mediastinal lymph node

Outcome Measures

Primary Outcomes (1)

• Consistency rate between preoperative prediction results and postoperative pathological results

  Compare postoperative lymph node pathology results with preoperative prediction results

  1 week after surgery

Secondary Outcomes (7)

• Postoperative complications

  30 days after surgery

• Postoperative recurrence rate

  2 years after surgery

• Disease-free survival

  2 years after surgery

• Overall survival

  2 years after surgery

• Intraoperative blood loss

  During the surgery

Study Arms (2)

Model group

EXPERIMENTAL

During surgery, lymph nodes predicted to be metastatic will be dissected based on the predicted results of the model.

Procedure: Lymph node dissection based on the model

Guideline group

ACTIVE COMPARATOR

During surgery, lymph nodes will be dissected based on the NCCN guidelines (2023).

Procedure: Lymph node dissection based on the guidelines

Interventions

Lymph node dissection based on the guidelines PROCEDURE

During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .

Guideline group

Lymph node dissection based on the model PROCEDURE

During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.

Model group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hexiao Tang, PhD

  Zhongnan Hospital

  STUDY CHAIR

Central Study Contacts

Hexiao Tang, PhD

CONTACT

15102723563; thx1245@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2025
• Primary Completion: March 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)