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

NCT04905056 | Recruiting Phase 2

• 1 other identifier: B2021-088R
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Progression

Outcome Measures

Primary Outcomes (1)

• progression free survival

  One year progression free survival after radiofrequency ablation of ground glass nodules

  1 years

Secondary Outcomes (1)

• overall survival

  1 years, 3 years, 5years

Study Arms (1)

ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

EXPERIMENTAL

Other: Ablation therapy

Interventions

Ablation therapy OTHER

Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 85 years;
• GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
• The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
• For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm
• The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest
• The patient is able to understand and comply with the study and has provided written informed consent

You may not qualify if:

• Patients who participated in any drug and / or medical device clinical trials within one month before the trial
• had severe disease conditions
• allergy to narcotic drugs
• had other autoimmune disease
• dementia or cognitive impairment can't cooperate with researchers
• any local treatment other than ablation was received within 4 weeks before the study

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Department of Thoracic Surgery, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qun Wang, Phd

CONTACT

86-21-64041990; 13301050210@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: May 27, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

CN (1)