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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1, Cohort 2: Survival After Initial Diagnosis | 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. | Time from initial diagnosis until the earliest record of death or end of the study period, up to 10 years. |
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Inclusion criteria:
No exclusion criteria are applied.
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan hospital | Beijing | 102208 | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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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
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Only patients diagnosed with DDLPS, who met all the inclusion criteria of having at least 2 documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) on or after January 1, 2013, and were ≥18 years at initial diagnosis, were included.
This was an observational cohort study conducted to investigate patient characteristics, current treatment patterns and outcomes in Chinese patients with dedifferentiated liposarcoma (DDLPS).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and were aged ≥18 years at initial diagnosis. Eligible patients were identified from January 1, 2013 to December 31, 2021 and were followed from index date until death, end of study period (December 31, 2022), or loss to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Cohort 1, Cohort 2: Survival After Initial Diagnosis | 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. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients with an existing diagnosis date were included in this analysis. | Posted | Median | 95% Confidence Interval | months | Time from initial diagnosis until the earliest record of death or end of the study period, up to 10 years. |
|
Adverse event information was not applicable for this study. All-cause mortality was recorded until end of the observation, up to 10 years.
This was an observational study and was not designed to assess adverse events, therefore safety reporting was not applicable for this study. Adverse events were not planned to be collected as defined in the study protocol. Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2023 | May 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2023 | May 5, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Cohort 1, Cohort 2: Total Number of Treatment Lines | 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. | At index date and during follow-up, up to 10 years. |
| Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | 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. | At index date and during follow-up, up to 10 years |
| Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | 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. | At index date and during follow-up, up to 10 years |
| Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | 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. | At index date and during follow-up, up to 10 years |
| Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy | Number of patients who received treatments with drugs classified as concurrent steroid therapy for both cohorts is reported. | At index date and during follow-up, up to 10 years |
| Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy | Number of patients who received treatments with drugs classified as concurrent immunosuppressant therapy for both cohorts is reported. | At index date and during follow-up, up to 10 years |
| Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy | Number of patients who received treatments with drugs classified as hormone replacement therapy for both cohorts is reported. | At index date and during follow-up, up to 10 years |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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).
| OG001 | 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. |
|
|
| Secondary | Cohort 1, Cohort 2: Total Number of Treatment Lines | 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. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and being age ≥18 years at initial diagnosis. | Posted | Median | Inter-Quartile Range | Count of treatment lines per patient | At index date and during follow-up, up to 10 years. |
|
|
|
| Secondary | Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type | 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. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients with non-missing data were included in the analysis. | Posted | Count of Participants | Participants | At index date and during follow-up, up to 10 years |
|
|
|
| Secondary | Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type | 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. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients with non-missing data were included in the analysis. | Posted | Count of Participants | Participants | At index date and during follow-up, up to 10 years |
|
|
|
| Secondary | Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type | 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. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and being age ≥18 years at initial diagnosis. Only patients with non-missing data were included in the analysis. | Posted | Count of Participants | Participants | At index date and during follow-up, up to 10 years |
|
|
|
| Secondary | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy | Number of patients who received treatments with drugs classified as concurrent steroid therapy for both cohorts is reported. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. | Posted | Count of Participants | Participants | At index date and during follow-up, up to 10 years |
|
|
|
| Secondary | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy | Number of patients who received treatments with drugs classified as concurrent immunosuppressant therapy for both cohorts is reported. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and being age ≥18 years at initial diagnosis. | Posted | Count of Participants | Participants | At index date and during follow-up, up to 10 years |
|
|
|
| Secondary | Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy | Number of patients who received treatments with drugs classified as hormone replacement therapy for both cohorts is reported. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and being age ≥18 years at initial diagnosis. | Posted | Count of Participants | Participants | At index date and during follow-up, up to 10 years |
|
|
|
| Primary | 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. | All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients who received at least one line of systemic antineoplastic treatment by the end of cohort identification period were included in this analysis. | Posted | Median | 95% Confidence Interval | months | Time from index date until the earliest record of death or end of the study period, up to 10 years. |
|
|
|
| 175 |
| 275 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 initiated 1L treatment afterwards or patients received adjuvant and/or neoadjuvant therapy only through follow-up will be included in Cohort 2. | 423 | 1,106 | 0 | 0 | 0 | 0 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D012509 | Sarcoma |
| Apatinib-based regimens |
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| Immune checkpoint inhibitor only |
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| Palbociclib |
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| Other |
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| Immune checkpoint inhibitor only |
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| Apatinib-based regimens |
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| Gemcitabine, Docetaxel |
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| Other |
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| Apatinib-based regimens |
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| Immune checkpoint inhibitor only |
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| Gemcitabine, Docetaxel |
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| Other |
|
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| OS after third line (3L) treatment |
|
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