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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05171413
Other study ID # HX-20211156
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2024

Study information

Verified date December 2021
Source West China Hospital
Contact Yuhan Yang, MD
Phone 8613258389785
Email yyh_1023@163.com
Is FDA regulated No
Health authority
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 soft tissue sarcoma and compared these models with currently available models.


Description:

We 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 soft tissue sarcoma. Secondly, we 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

Study Design


Related Conditions & MeSH terms


Intervention

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

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 soft tissue sarcoma. 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
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