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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06115681
Other study ID # 1403-0024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2024
Est. completion date May 15, 2024

Study information

Verified date May 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 1390
Est. completion date May 15, 2024
Est. primary completion date May 15, 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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT02846987 - Study of Abemaciclib in Dedifferentiated Liposarcoma Phase 2
Terminated NCT04979442 - Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma Phase 3
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Active, not recruiting NCT04242238 - Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas Phase 1
Withdrawn NCT00969917 - Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma Phase 2
Active, not recruiting NCT03651375 - Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall Phase 2
Terminated NCT03604783 - Phase 1, First-in-human Study of Oral TP-1287 in Patients With Advanced Solid Tumors Phase 1
Not yet recruiting NCT05496569 - TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma Phase 2

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