NCT04631770 Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage I GGN NSCLC
| NCT ID | NCT04631770 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Lung Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,362 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2024-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,362 participants in total. It began in 2022-05-01 with a primary completion date of 2024-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.
Eligibility Criteria
Inclusion Criteria: * Thin-slice HRCT shows single GGN with C/T ≤ 0.5 and no lymph node metastasis; * Clinical stage IA NSCLC (TNM 8th classification) diagnosed prior or in surgery; * No history of malignancies within past 5 years or lung surgery; * No anti-cancer treatment prior to surgery. Exclusion Criteria: * Simultaneous or metachronous (within the past 5 years) double cancers; * Active bacterial or fungous infection; * Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema; * Systemic steroidal medication; * Uncontrollable diabetes mellitus; (vi) Uncontrollable hypertension or history of severe heart disease, heart failure.
Contact & Investigator
Zhenfa Zhenfa, MD
PRINCIPAL INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT04631770 clinical trial?
This trial is open to participants of all sexes, studying Lung Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04631770 currently recruiting?
Yes, NCT04631770 is actively recruiting participants. Contact the research team at zhangzhenfa1973@163.com for enrollment information.
Where is the NCT04631770 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT04631770 clinical trial?
NCT04631770 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Zhenfa Zhenfa, MD at Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 1,362 participants.