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NCT Number: NCT04905056

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

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

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Thoracic Surgery, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Qun Wang, phd

CONTACT

[email protected]

86-21-64041990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ablation therapy

Other

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

Primary outcomes

  1. progression free survival

    Time frame: 1 years

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

Secondary outcomes

  1. overall survival

    Time frame: 1 years, 3 years, 5years

    overall survival after radiofrequency ablation of ground glass nodules

Study contacts

Contact information is provided by the study sponsor or research team.

Qun Wang, Phd

CONTACT

[email protected]

86-21-64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2028
First posted
May 27, 2021
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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