Cryoablation for Advanced Bone and Soft Tissue Tumors

February 5, 2024 updated by: Wang Jiaqiang, Henan Cancer Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wang Jiaqiang, Dr
  • Phone Number: 13592413731
  • Email: wjqwtj@126.com

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Department of Bone and Soft Tissue ,Henan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cryoablation of selected tumor lesions in patients with metastatic/operatively unresectable bone and soft tissue sarcomas

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Not applicable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cryoablation
Cryoablation of selected tumor lesions
Procedure: Cryoablation
Cryoablation of selected tumor lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rates
Time Frame: 12 months after surgery
1-year survival rate
12 months after surgery
There was no local recurrence survival rate
Time Frame: 12 months after surgery
The 1-year survival rate without local recurrence
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Estimated)

October 28, 2024

Study Completion (Estimated)

October 28, 2024

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZZUSC-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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