Real-world Study of Dedifferentiated Liposarcoma Patients in China

Completed

• Conditions: Dedifferentiated Liposarcoma

• Registration Number: NCT06115681
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Study Start: 2024-03-13
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Results First Submitted: 2025-05-14
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Results First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1390

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohort 1: Overall Survival	Time from index date until the earliest record of death or end of the study period, up to 10 years.	Overall survival (OS) as an event for each patient in Cohort 1 was 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 was censored at the last activity date before the end of the study period.

Secondary Outcome Measures

Name	Time	Method
Cohort 1, Cohort 2: Survival After Initial Diagnosis	Time from initial diagnosis until the earliest record of death or end of the study period, up to 10 years.	Survival after initial diagnosis for each patient was defined as the date of death minus the date of initial diagnosis. For patients with no record of death, survival after initial diagnosis was censored at the last activity date before the end of the study period.
Cohort 1, Cohort 2: Total Number of Treatment Lines	At index date and during follow-up, up to 10 years.	The total number of treatment lines in both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.
Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type	At index date and during follow-up, up to 10 years	Number of patients with first line (1L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.
Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type	At index date and during follow-up, up to 10 years	Number of patients with second line (2L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy	At index date and during follow-up, up to 10 years	Number of patients who received treatments with drugs classified as hormone replacement therapy for both cohorts is reported.
Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type	At index date and during follow-up, up to 10 years	Number of patients with third line (3L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy	At index date and during follow-up, up to 10 years	Number of patients who received treatments with drugs classified as concurrent steroid therapy for both cohorts is reported.
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy	At index date and during follow-up, up to 10 years	Number of patients who received treatments with drugs classified as concurrent immunosuppressant therapy for both cohorts is reported.

Trial Locations

Locations (1)

Beijing Jishuitan hospital; 🇨🇳 Beijing, China