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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194605
• Other study ID #: HX-20211288
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2022
• Source: West China Hospital
• Contact: Yuhan Yang, MD
• Phone: 8613258389785
• Email: yyh_1023[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Receiving no treatment before diagnosis
• With written informed consent

Exclusion Criteria:

• Clinical data missing
• Without written informed consent

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Other:
• Prediction model
We develop and validate clinical models to predict treatment responses and survival outcomes in patients with biopsy-proven with osteosarcoma.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response	The primary outcome was the evaluation of treatment response to individualized therapy in patients with osteosarcoma.	At least 1-year follow up
Primary	Progression-free survival outcomes	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.	At least 5-year follow up
Primary	Overall survival outcomes	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.	At least 5-year follow up