Predictive Models of Treatment Responses and Survival Outcomes in Patients With Osteosarcoma

Recruiting

• Conditions: Osteosarcoma
• Interventions: Other: Prediction model

• Registration Number: NCT05194605
• Lead Sponsor: West China Hospital

Brief Summary

The aim of this study was to developed and validated models to predict therapeutic responses and patients' survivals in patients with osteosarcoma and compared these models with currently available models.

Detailed Description

The investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict treatment responses and survival outcomes in patients with biopsy-proven osteosarcoma. Secondly, the investigator aimed to compare the predictive accuracy with currently available noninvasive model.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-15
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Receiving no treatment before diagnosis
• With written informed consent

Exclusion Criteria

• Clinical data missing
• Without written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Prediction model	The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort.
Retrospective cohort	Prediction model	The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort.

Primary Outcome Measures

Name	Time	Method
Progression-free survival outcomes	At least 5-year follow up	The endpoint was defined as the occurrence of progression or recurrence, or the last follow-up. Patients were followed from the day of histological diagnosis until the occurrence of progression or recurrence, or last visit. The outcome was evaluated by an experienced oncologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.
Treatment response	At least 1-year follow up	The primary outcome was the evaluation of treatment response to individualized therapy in patients with osteosarcoma.
Overall survival outcomes	At least 5-year follow up	The endpoint was defined as the occurrence of death or the last follow-up. Patients were followed from the day of histological diagnosis until the occurrence of progression or recurrence or last visit. The outcome was evaluated by an experienced oncologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China