ProgressionPhase 2NCT04905056
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 Phase 2 study testing Ablation therapy in people with Progression, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Progression
- What is being tested?
- Ablation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2028
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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, 1 recruiting
- Recruiting
Department of Thoracic Surgery, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Qun Wang, phd, 86-21-64041990, 13301050210@fudan.edu.cn
About this study
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
- Being tested
- Ablation therapy
- Medical subject headings
- Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation therapyOther
Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules
| Study group | Role | What they receive |
|---|---|---|
| ablation therapy in the treatment of lung cancer presenting as ground-glass nodules | Experimental | Not described Receives: Other: Ablation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
One year progression free survival after radiofrequency ablation of ground glass nodules
Measured: 1 years
Secondary outcomes (1)
overall survival
overall survival after radiofrequency ablation of ground glass nodules
Measured: 1 years, 3 years, 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProgressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Junjie, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905056
- Sponsor's protocol ID
- B2021-088R
- Status last verified
- May 2021
- First submitted
- 23 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04905056
- Acronym / sponsor ID
- B2021-088R
- Conditions
- Progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 May 2021 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ablation therapy in the treatment of lung cancer presenting as ground-glass nodules | Experimental | Other: Ablation therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Ablation therapyAblation therapy in the treatment of lung cancer presenting as ground-glass nodules | Other | ablation therapy in the treatment of lung cancer presenting as ground-glass nodules |
Primary outcome
progression free survival
Time frame: 1 years
One year progression free survival after radiofrequency ablation of ground glass nodules
1 secondary outcome
overall survival
Time frame: 1 years, 3 years, 5years
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 27 May 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ablation therapy in people with Progression, run by Shanghai Zhongshan 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 May 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qun Wang, Phd (86-21-64041990, 13301050210@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 1 years). 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 27 May 2021.