Non-small Cell Lung CancerNCT06768853
The Accuracy of Targeted Lymph Node Dissection of Non-small Cell Lung Cancer Patients According to Predictive Models
A study testing Lymph node dissection based on the guidelines and Lymph node dissection based on the model in people with Non-small Cell Lung Cancer, run by Zhongnan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Lymph node dissection based on the guidelines and Lymph node dissection based on the model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
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- 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.
Who cannot join
- 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;
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- Severe underlying lung diseases such as interstitial lung disease, pulmonary fibrosis, or emphysema are complicated;
- Concomitant mental illness;
- Pregnant/lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Hexiao Tang, PhD, 15102723563 ext. +86, thx1245@sina.com
About this study
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
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Lymph node dissection based on the guidelines, Lymph node dissection based on the model
- Keywords
- lung cancer, mediastinal lymph node
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph node dissection based on the guidelinesProcedure or surgery
During surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) .
Lymph node dissection based on the modelProcedure or surgery
During surgery, lymph nodes will be dissected based on the predicted lymph node status by the model.
| Study group | Role | What they receive |
|---|---|---|
| Model group | Experimental | During surgery, lymph nodes predicted to be metastatic will be dissected based on the predicted results of the model. Receives: 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). Receives: Procedure: Lymph node dissection based on the guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency rate between preoperative prediction results and postoperative pathological results
Compare postoperative lymph node pathology results with preoperative prediction results
Measured: 1 week after surgery
Secondary outcomes (7)
Postoperative complications
Observation of complications within 30 days after surgery
Measured: 30 days after surgery
Postoperative recurrence rate
Observe for recurrence within 2 years after surgery
Measured: 2 years after surgery
Disease-free survival
Follow up after surgery to determine if there is any recurrence or metastasis, and calculate disease-free survival
Measured: 2 years after surgery
Overall survival
Follow up after surgery to determine if there is death, and calculate overall survival
Measured: 2 years after surgery
Intraoperative blood loss
Record intraoperative blood loss
Measured: During the surgery
Postoperative drainage volume
Record postoperative drainage volume
Measured: 2 weeks after surgery
Postoperative drainage time
Record the time from the end of the surgery to the removal of the drain tube
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hexiao Tang, PhD, Study chair, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768853
- Sponsor's protocol ID
- 20240329
- Status last verified
- Oct 2024
- First submitted
- 29 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06768853
- Acronym / sponsor ID
- 20240329
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- lung cancer, mediastinal lymph node
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model group | Experimental | Procedure: Lymph node dissection based on the modelDuring surgery, lymph nodes predicted to be metastatic will be dissected based on the predicted results of the model. |
| Guideline group | Active comparator | Procedure: Lymph node dissection based on the guidelinesDuring surgery, lymph nodes will be dissected based on the NCCN guidelines (2023). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymph node dissection based on the guidelinesDuring surgery, mediastinal lymph nodes will be dissected based on the NCCN guidelines (2023) . | Procedure or surgery | Guideline group |
| Lymph node dissection based on the modelDuring surgery, lymph nodes will be dissected based on the predicted lymph node status by the model. | Procedure or surgery | Model group |
Primary outcome
Consistency rate between preoperative prediction results and postoperative pathological results
Time frame: 1 week after surgery
Compare postoperative lymph node pathology results with preoperative prediction results
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hexiao Tang, PhD study chair
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymph node dissection based on the guidelines and Lymph node dissection based on the model in people with Non-small Cell Lung Cancer, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hexiao Tang, PhD (15102723563 ext. +86, thx1245@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency rate between preoperative prediction results and postoperative pathological results (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.