NCT06162962

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2000

Completed
23.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

23.9 years

First QC Date

November 29, 2023

Last Update Submit

December 6, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Overall Survival rate (OS)

    Oncological outcomes

    2000-2019

  • Progression-Free Survival rate (PFS)

    Oncological outcomes

    2000-2019

  • Local recurrence rate(LRR)

    Oncological outcomes

    2000-2019

  • Metastasis rate

    Oncological outcomes

    2000-2019

  • Final limb-salvage and amputation rate

    Oncological outcomes

    2000-2019

  • Prosthesis survival rate

    Functional outcomes

    2000-2019

  • Musculoskeletal Tumor Society (MSTS) score

    Functional outcomes

    2000-2019

  • Complications

    Functional outcomes

    2000-2019

Study Arms (5)

age groups

The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.

Other: Retrospective analysis

surgical methods

The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.

Other: Retrospective analysis

type of prosthesis

The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.

Other: Retrospective analysis

primary tumor location

The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.

Other: Retrospective analysis

Enneking stage

The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded.

Other: Retrospective analysis

Interventions

Retrospective analysis

Enneking stageage groupsprimary tumor locationsurgical methodstype of prosthesis

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A retrospective analysis of 345 pediatric patients with lower-limb osteosarcoma admitted to our department between 2000 and 2019 was conducted.

You may qualify if:

  • Diagnosed lower limb osteosarcoma patients under the age of 14;
  • Performing tumor resection treatment in our hospital;
  • There is complete clinical registration data available.

You may not qualify if:

  • Not undergoing surgical treatment in our hospital;
  • Age older than 14 years old;
  • No available clinical registration data or lost follow-up patients;
  • Non lower limb osteosarcoma patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changye Zou

Guangzhou, Guangdong, 518010, China

Location

Related Publications (1)

  • Xu M, Tu J, Huang Y, Wang B, Zhao Z, Lin T, Huang G, Yin J, Xie X, Shen J, Zou C. Comparison of oncological and functional outcomes in Lower-limb osteosarcoma pediatric patients: a large single-center retrospective cohort study. Int J Surg. 2024 Jul 1;110(7):4208-4220. doi: 10.1097/JS9.0000000000001340.

MeSH Terms

Conditions

OsteosarcomaLeg Injuries

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 8, 2023

Study Start

January 1, 2000

Primary Completion

November 23, 2023

Study Completion

November 23, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
SCI online. The datasets are available from the corresponding author on reasonable request.
Access Criteria
The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.

Locations