Real-world Study of Dedifferentiated Liposarcoma Patients in China

Study Overview
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Brief Summary
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This study will characterize patients with dedifferentiated liposarcoma (DDLPS) in China, including an understanding of demographic, and clinical characteristics as well as treatment patterns and clinical outcomes associated with the current real-world treatment.

Official Title
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Demographic, Clinical Characteristics, and Treatment Outcomes Associated With Dedifferentiated Liposarcoma Patients in China

Conditions
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Dedifferentiated Liposarcoma

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient has two or more documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) network on or after January 1, 2013. Patient has a confirmed diagnosis of dedifferentiated liposarcoma (DDLPS) during his/her lifetime. At least 18 years old at the date of initial diagnosis. No exclusion criteria are applied.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients with unresectable locally advanced or metastatic differentiated liposarcoma (DDLPS) who received at least one line of systemic antineoplastic treatment by the end of cohort identification period (index date = start date of first line (1L) treatment). | |
| Cohort 2<br>Patients with DDLPS who have not initiated 1L systemic antineoplastic treatment by the end of cohort identification period (index date = date of initial DDLPS diagnosis during cohort identification period). Patients initiated 1L treatment afterwards or patients received adjuvant and/or neoadjuvant therapy only through follow-up will be included in Cohort 2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1: Overall survival | Overall survival (OS) as an event for each patient in Cohort 1 will be defined as the date of death minus the index date or the start day of each line of therapy (LOT). For patients with no record of death, OS will be censored at the last activity date before the end of the study period. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1, Cohort 2: Survival after initial diagnosis | Survival after initial diagnosis for each patient will be defined as the date of death minus the date of initial diagnosis. For patients with no record of death, survival after initial diagnosis will be censored at the last activity date before the end of the study period. | Up to 10 years | 
| Cohort 1, Cohort 2: First line (1L) of therapy by treatment type |  | Up to 10 years | 
| Cohort 1, Cohort 2: Second line (2L) of therapy by treatment type |  | Up to 10 years | 
| Cohort 1, Cohort 2: Third line (3L) of therapy by treatment type |  | Up to 10 years | 
| Cohort 1, Cohort 2: Total number of treatment lines |  | Up to 10 years | 
| Cohort 1, Cohort 2: Number of treatments with drugs classified as steroid therapy |  | Up to 10 years | 
| Cohort 1, Cohort 2: Number of treatments with drugs classified as concurrent immunosuppressant therapy |  | Up to 10 years | 
| Cohort 1, Cohort 2: Number of treatments with drugs classified as hormone replacement therapy |  | Up to 10 years |