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

NCT05171413 | Unknown

• 1 other identifier: HX-20211156
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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

Prospective cohort

The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort.

Other: Prediction model

Interventions

Prediction model OTHER

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

Prospective cohort; Retrospective cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Receiving no treatment before diagnosis
• With written informed consent

You may not qualify if:

• Clinical data missing
• Without written informed consent

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 6100041, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yuhan Yang, MD

CONTACT

8613258389785; yyh_1023@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: December 28, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)