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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06162962
Other study ID # Changye Zou
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2000
Est. completion date November 23, 2023

Study information

Verified date December 2023
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective analysis of specific characteristics of complications and long-term oncological and function outcomes in lower-limb osteosarcoma pediatric patients.


Description:

Clinical and functional outcomes were compared based on age groups, surgical methods, type of prosthesis, and primary tumor location. Patients were divided into the Low-age group (≤10 years old) and the High-age group (>10 years old). Overall Survival rate (OS), Progression-Free Survival rate (PFS), and prosthesis survival rate were assessed using Kaplan-Meier curves, and non-parametric survival analysis (log-rank test) was used for comparison. The incidence of complications, local relapse rate (LRR), metastasis rate, final limb-salvage and amputation rate, and Musculoskeletal Tumor Society (MSTS) score of different independent groups were further evaluated using χ2 test or Fisher's exact test, and t-test was employed to evaluate the measurement data.


Recruitment information / eligibility

Status Completed
Enrollment 345
Est. completion date November 23, 2023
Est. primary completion date November 23, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 14 Years
Eligibility Inclusion Criteria: 1. Diagnosed lower limb osteosarcoma patients under the age of 14; 2. Performing tumor resection treatment in our hospital; 3. There is complete clinical registration data available. Exclusion Criteria: 1. Not undergoing surgical treatment in our hospital; 2. Age older than 14 years old; 3. No available clinical registration data or lost follow-up patients; 4. Non lower limb osteosarcoma patients.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Retrospective analysis
Retrospective analysis

Locations

Country Name City State
China Changye Zou Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Changye Zou

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival rate (OS) Oncological outcomes 2000-2019
Primary Progression-Free Survival rate (PFS) Oncological outcomes 2000-2019
Primary Local recurrence rate(LRR) Oncological outcomes 2000-2019
Primary Metastasis rate Oncological outcomes 2000-2019
Primary Final limb-salvage and amputation rate Oncological outcomes 2000-2019
Primary Prosthesis survival rate Functional outcomes 2000-2019
Primary Musculoskeletal Tumor Society (MSTS) score Functional outcomes 2000-2019
Primary Complications Functional outcomes 2000-2019
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