NCT05615545

Brief 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. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
Last Updated

February 7, 2024

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

November 7, 2022

Last Update Submit

February 5, 2024

Conditions

SarcomaCryoablation

Outcome Measures

Primary Outcomes (2)

  • Survival rates

    1-year survival rate

    12 months after surgery

  • There was no local recurrence survival rate

    The 1-year survival rate without local recurrence

    12 months after surgery

Study Arms (1)

Cryoablation

Cryoablation of selected tumor lesions

Procedure: Cryoablation

Interventions

CryoablationPROCEDURE

Cryoablation of selected tumor lesions

Cryoablation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Bone and Soft Tissue ,Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Central Study Contacts

Wang Jiaqiang, Dr

CONTACT

13592413731wjqwtj@126.com

Tian Zhichao, Dr

CONTACT

18737187831tianzhichaoyy@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 14, 2022

Study Start

March 10, 2022

Primary Completion

October 28, 2024

Study Completion

October 28, 2024

Last Updated

February 7, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)