Real-world Study of Dedifferentiated Liposarcoma Patients in China

Dedifferentiated Liposarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06115681
• Other study ID #: 1403-0024
• Status: Active, not recruiting
• Start date: March 13, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1400
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dedifferentiated Liposarcoma
• Liposarcoma

Locations

Country	Name	City	State
China	Beijing Jishuitan hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cohort 1, Cohort 2: First line (1L) of therapy by treatment type		Up to 10 years
Secondary	Cohort 1, Cohort 2: Second line (2L) of therapy by treatment type		Up to 10 years
Secondary	Cohort 1, Cohort 2: Third line (3L) of therapy by treatment type		Up to 10 years
Secondary	Cohort 1, Cohort 2: Total number of treatment lines		Up to 10 years
Secondary	Cohort 1, Cohort 2: Number of treatments with drugs classified as steroid therapy		Up to 10 years
Secondary	Cohort 1, Cohort 2: Number of treatments with drugs classified as concurrent immunosuppressant therapy		Up to 10 years
Secondary	Cohort 1, Cohort 2: Number of treatments with drugs classified as hormone replacement therapy		Up to 10 years

External Links

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