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NCT Number: NCT06115681

Real-world Study of Dedifferentiated Liposarcoma Patients in China

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.

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Key information

Conditions

Dedifferentiated Liposarcoma Liposarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Jishuitan hospital

Beijing, 102208, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cohort 1: Overall Survival

    Time frame: 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 outcomes

  1. Cohort 1, Cohort 2: Survival After Initial Diagnosis

    Time frame: 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.

  2. Cohort 1, Cohort 2: Total Number of Treatment Lines

    Time frame: 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.

  3. Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type

    Time frame: 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.

  4. Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type

    Time frame: 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.

  5. Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type

    Time frame: 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.

  6. Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy

    Time frame: 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.

  7. Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy

    Time frame: 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.

  8. Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2023
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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