SarcomaNCT05615545
Cryoablation for Advanced Bone and Soft Tissue Tumors
An observational study of Sarcoma and Cryoablation, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. All eligible patients were enrolled. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma, Cryoablation
- What is being tested?
- Cryoablation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 28 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cryoablation of selected tumor lesions in patients with metastatic/operatively unresectable bone and soft tissue sarcomas
Who may be able to join
- No age restriction, male or female.
- The pathological diagnosis was a subtype of bone and soft tissue sarcoma.
- The clinical stage was determined to be metastatic or locally unresectable bone and soft tissue sarcoma.
- At least one cryoablation of tumor lesions was performed in our hospital.
- Target lesions can be evaluated according to the efficacy evaluation criteria for solid tumors (RECIST; Version 1.1) Measure diameter changes.
- Follow-up data were complete.
Who cannot join
- Not applicable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Bone and Soft Tissue ,Henan Cancer Hospital
Zhengzhou, Henan, 450008
Tian Zhichao, Dr., +8618737187831, tianzhichhaoyy@163.com
About this study
Official title: Safety and Efficacy of Cryoablation in the Treatment of Advanced Bone and Soft Tissue Tumors: a Single-center Retrospective Study
This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. All eligible patients were enrolled. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.
Read the detailed description
This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. Clinical data of eligible patients were scheduled to be retrospectively collected from December 2016 to February 28, 2022. All patients eligible for inclusion. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.
- Conditions
- Sarcoma, Cryoablation
- Being tested
- Cryoablation
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Cryoablation of selected tumor lesions
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Cryoablation of selected tumor lesions Receives: Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rates
1-year survival rate
Measured: 12 months after surgery
There was no local recurrence survival rate
The 1-year survival rate without local recurrence
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start10 Mar 2022
- Primary completion28 Oct 2024 (estimated)
- Study completion28 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Jiaqiang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615545
- Sponsor's protocol ID
- ZZUSC-10
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cryoablation in the Treatment of Advanced Bone and Soft Tissue Tumors: a Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT05615545
- Acronym / sponsor ID
- ZZUSC-10
- Conditions
- Sarcoma, Cryoablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 28 Oct 2024 (estimated)
- Study completion
- 28 Oct 2024 (estimated)
- First posted
- 14 Nov 2022 (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.
This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. All eligible patients were enrolled. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.
Detailed description
This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. Clinical data of eligible patients were scheduled to be retrospectively collected from December 2016 to February 28, 2022. All patients eligible for inclusion. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | – | Procedure: CryoablationCryoablation of selected tumor lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cryoablation of selected tumor lesions in patients with metastatic/operatively unresectable bone and soft tissue sarcomas
Key inclusion criteria (6 listed)
- No age restriction, male or female.
- The pathological diagnosis was a subtype of bone and soft tissue sarcoma.
- The clinical stage was determined to be metastatic or locally unresectable bone and soft tissue sarcoma.
- At least one cryoablation of tumor lesions was performed in our hospital.
- Target lesions can be evaluated according to the efficacy evaluation criteria for solid tumors (RECIST; Version 1.1) Measure diameter changes.
Key exclusion criteria (1 listed)
- Not applicable.
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 |
|---|---|---|
| CryoablationCryoablation of selected tumor lesions | Procedure or surgery | Cryoablation |
Primary outcome
Survival rates
Time frame: 12 months after surgery
1-year survival rate
There was no local recurrence survival rate
Time frame: 12 months after surgery
The 1-year survival rate without local recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Cryoablation, run by Henan Cancer 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 1 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Jiaqiang, Dr (13592413731, wjqwtj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rates (time frame: 12 months after surgery). The study lists 2 primary outcomes in all. 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 7 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.