OsteosarcomaNCT06162962
Oncological and Functional Outcomes in Lower Limb Osteosarcoma Pediatric Patient
An observational study of Osteosarcoma and Pediatric, run by Changye Zou at 1 site in China.
Trial summary
Retrospective analysis of specific characteristics of complications and long-term oncological and function outcomes in lower-limb osteosarcoma pediatric patients. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Osteosarcoma, Pediatric, Lower Limb Injury
- What is being tested?
- Retrospective analysis
- How many people
- 345 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2000to 23 Nov 2023
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: A retrospective analysis of 345 pediatric patients with lower-limb osteosarcoma admitted to our department between 2000 and 2019 was conducted.
Who may be able to join
- Diagnosed lower limb osteosarcoma patients under the age of 14;
- Performing tumor resection treatment in our hospital;
- There is complete clinical registration data available.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Orthopedic Oncology, The First Affiliated Hospital of Sun Yat-sen University
Retrospective analysis of specific characteristics of complications and long-term oncological and function outcomes in lower-limb osteosarcoma pediatric patients.
Read the detailed 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.
- Conditions
- Osteosarcoma, Pediatric, Lower Limb Injury, Outcome
- Being tested
- Retrospective analysis
- Medical subject headings
- Osteosarcoma, Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysisOther
Retrospective analysis
| Study group | Role | What they receive |
|---|---|---|
| age groups | The general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Retrospective analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival rate (OS)
Oncological outcomes
Measured: 2000-2019
Progression-Free Survival rate (PFS)
Oncological outcomes
Measured: 2000-2019
Local recurrence rate(LRR)
Oncological outcomes
Measured: 2000-2019
Metastasis rate
Oncological outcomes
Measured: 2000-2019
Final limb-salvage and amputation rate
Oncological outcomes
Measured: 2000-2019
Prosthesis survival rate
Functional outcomes
Measured: 2000-2019
Musculoskeletal Tumor Society (MSTS) score
Functional outcomes
Measured: 2000-2019
Complications
Functional outcomes
Measured: 2000-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jan 2000
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changye Zou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Changye Zou, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162962
- Sponsor's protocol ID
- Changye Zou
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.
Publications
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.
PubMed 38471042
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Orthopedic Oncology, The First Affiliated Hospital of Sun Yat-sen University
- ClinicalTrials.gov ID
- NCT06162962
- Acronym / sponsor ID
- Changye Zou
- Conditions
- Osteosarcoma, Pediatric, Lower Limb Injury, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Changye ZouUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 8 Dec 2023 (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.
Retrospective analysis of specific characteristics of complications and long-term oncological and function outcomes in lower-limb osteosarcoma pediatric patients.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| age groups | – | Other: Retrospective analysisThe general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded. |
| surgical methods | – | Other: Retrospective analysisThe general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded. |
| type of prosthesis | – | Other: Retrospective analysisThe general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded. |
| primary tumor location | – | Other: Retrospective analysisThe general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded. |
| Enneking stage | – | Other: Retrospective analysisThe general characteristic of patients and clinical data including age, Enneking stage, surgical methods, type of prosthesis, primary tumor location were recorded. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A retrospective analysis of 345 pediatric patients with lower-limb osteosarcoma admitted to our department between 2000 and 2019 was conducted.
Key inclusion criteria (3 listed)
- Diagnosed lower limb osteosarcoma patients under the age of 14;
- Performing tumor resection treatment in our hospital;
- There is complete clinical registration data available.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Retrospective analysisRetrospective analysis | Other | Enneking stage, age groups, primary tumor location, surgical methods, type of prosthesis |
Primary outcome
Overall Survival rate (OS)
Time frame: 2000-2019
Oncological outcomes
Progression-Free Survival rate (PFS)
Time frame: 2000-2019
Oncological outcomes
Local recurrence rate(LRR)
Time frame: 2000-2019
Oncological outcomes
Metastasis rate
Time frame: 2000-2019
Oncological outcomes
Final limb-salvage and amputation rate
Time frame: 2000-2019
Oncological outcomes
Prosthesis survival rate
Time frame: 2000-2019
Functional outcomes
Musculoskeletal Tumor Society (MSTS) score
Time frame: 2000-2019
Functional outcomes
Complications
Time frame: 2000-2019
Functional outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 38471042Xu 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.
- Individual participant dataSharing planned: Yes. The datasets are available from the corresponding author (zouchy@mail.sysu.edu.cn) on reasonable request after SCI online.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteosarcoma and Pediatric, run by Changye Zou 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival rate (OS) (time frame: 2000-2019). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162962, which also lists 1 linked publication.
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 8 Dec 2023.