Actively Recruiting
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Led by Shanghai Zhongshan Hospital · Updated on 2021-05-27
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase II clinical study at two centers to assess the safety and effectiveness of ablation therapy for treating lung cancer that appears as ground-glass nodules on lung CT scans. This study focuses on patients with such nodules that have not decreased after 3 months and meet specific size and progression criteria. The study is sponsored by Shanghai Zhongshan Hospital and aims to provide important data on this treatment approach for lung cancer progression. Participants will receive ablation therapy targeting ground-glass nodules in the lungs. This single-arm study involves no comparison group and no blinding. Ablation therapy is being evaluated as an alternative for patients who cannot tolerate surgery or have multiple nodules that cannot be fully removed by operation. The treatment focuses on nodules larger than 8 mm but smaller than 3 cm, especially those showing progression. During the study, participants will be monitored for progression-free survival over one year as the primary outcome. Secondary outcomes include overall survival evaluated at one, three, and five years. Participants will undergo lung CT scans and other assessments as needed to track treatment effects and safety. The total participation period extends up to five years for long-term follow-up of survival outcomes.
CONDITIONS
Brief Title
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 85 years
- Ground-glass nodule diagnosed by lung CT and not reduced after 3 months
- Maximum diameter of the nodule is larger than 8 mm and smaller than 3 cm
- For single nodule: clear progression in pure ground-glass nodule or solid part of mixed nodules is 2 mm or more
- Patients unable to tolerate surgery or with multiple nodules that cannot be fully removed, or had surgery in the same chest side
- Able to understand and comply with the study and provide written informed consent
You will not qualify if you...
- Participation in any drug or medical device clinical trial within one month before this study
- Severe disease conditions
- Allergy to narcotic drugs
- Presence of other autoimmune diseases
- Dementia or cognitive impairment preventing cooperation
- Received any local treatment other than ablation within 4 weeks before the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until ablation therapy is completed
Participants receive ablation therapy for lung cancer presenting as ground-glass nodules.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants are monitored for safety and effectiveness after ablation therapy, including survival and progression assessments.
Periodic visits over 1 to 5 years
Trial Site Locations
Total: 1 location
1
Department of Thoracic Surgery, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Q
Qun Wang, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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