Predictive Models of Treatment Responses and Survival Outcomes in Patients With Soft Tissue Sarcoma

December 24, 2021 updated by: Yuhan Yang, West China Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 6100041
        • Recruiting
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with soft tissue sarcoma who were diagnosed histologically with definite pathologic specimens.

Description

Inclusion Criteria:

  • Receiving no treatment before diagnosis
  • With written informed consent

Exclusion Criteria:

  • Clinical data missing
  • Without written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective cohort
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.
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.
Prospective cohort
The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival outcomes
Time Frame: 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.
At least 5-year follow up
Overall survival outcomes
Time Frame: 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.
At least 5-year follow up
Treatment response
Time Frame: At least 1-year follow up
The primary outcome was the evaluation of treatment response to individualized therapy in patients with soft tissue sarcoma.
At least 1-year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

December 24, 2021

First Submitted That Met QC Criteria

December 24, 2021

First Posted (ACTUAL)

December 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 24, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX-20211156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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