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NCT06768853Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
29 Dec 2024
Start date
1 Jan 2025
Primary completion date
31 Mar 2025
Lead sponsor
Zhongnan Hospital
Diseases
Lung cancer
NCT number
NCT06768853

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Jan 2025 to the primary completion date, 31 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of thoracic surgery;
  • A history of severe heart failure, myocardial infarction, cerebral infarction, and pneumonia within 6 months prior to surgery;
  • Concurrent active bacterial or fungal infections;
  • Concomitant mental illness;

Other illness

  • Chest CT suggests multiple primary lung cancer or metastatic cancer;
  • Previous history of malignant tumors;
  • History of neoadjuvant therapy;
  • Severe underlying lung diseases such as interstitial lung disease, pulmonary fibrosis, or emphysema are complicated;

Other

  • Pregnant/lactating women.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongnan Hospital of Wuhan University
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.