NCT06115681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

October 27, 2023

Results QC Date

May 14, 2025

Last Update Submit

July 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cohort 1: Overall Survival

    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.

    Time from index date until the earliest record of death or end of the study period, up to 10 years.

Secondary Outcomes (8)

  • 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.

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

    At index date and during follow-up, up to 10 years.

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

    At index date and during follow-up, up to 10 years

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

    At index date and during follow-up, up to 10 years

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

    At index date and during follow-up, up to 10 years

  • +3 more secondary outcomes

Study Arms (2)

DDLPS patients with 1L treatment at index date (Cohort 1)

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).

DDLPS patients without 1L treatment at index date (Cohort 2)

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 who initiated 1L treatment afterwards or patients who received adjuvant and/or neoadjuvant therapy only through follow-up were included in Cohort 2.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) network on or after January 1, 2013 and confirmed dedifferentiated liposarcoma (DDLPS).

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Jishuitan hospital

Beijing, 102208, China

Location

Related Links

MeSH Terms

Conditions

Liposarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Adipose TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 3, 2023

Study Start

March 13, 2024

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

July 10, 2025

Results First Posted

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Locations