UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045580 |
|---|---|
| Receipt number | R000052036 |
| Scientific Title | Multicenter retrospective study of usefulness of the pretreatment inflammatory biomarker for the uterine sarcoma |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2025/03/31 13:58:52 |
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Basic information
Public title
Multicenter retrospective study of usefulness of the pretreatment inflammatory biomarker for the uterine sarcoma
Acronym
Multicenter retrospective study of usefulness of the pretreatment inflammatory biomarker for the uterine sarcoma
Scientific Title
Multicenter retrospective study of usefulness of the pretreatment inflammatory biomarker for the uterine sarcoma
Scientific Title:Acronym
Multicenter retrospective study of usefulness of the pretreatment inflammatory biomarker for the uterine sarcoma
Region
| Japan |
Condition
Condition
Uterine sarcoma,
Uterine carcinosarcoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Search for biomarkers associated with prognosis of uterine sarcoma, including carcinosarcoma.
Basic objectives2
Others
Basic objectives -Others
Relationship between uterine sarcoma and pretreatment inflammatory biomarker.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who received surgery from January 2008 to December 2017, and be diagnosed malignant mesenchymal tumors.
Malignant mesenchymal tumors include the following:
mooth muscle tumor of uncertain malignant potential (STUMP)
Leiomyosarcoma
Low-grade endometrial stromal sarcoma
High-grade endometrial stromal sarcoma
Undifferentiated uterine sarcoma
Uterine tumor resembling ovarian sex cord tumor(UTROSCT)
Rhabdomyosarcoma
Perivascular epithelioid cell tumor(PEComa)
Adenosarcoma
Carcinosarcoma
Key exclusion criteria
Patients who are complicated with blood malignancy such as leukemia.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mandai |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
Shougoin Kawaharachou 54, Sakyouku, Kyoto
TEL
0757513269
mandai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
Shougoin Kawaharachou 54, Sakyouku, Kyoto
TEL
0757513269
Homepage URL
mandai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of Gynecology and Obstetrics
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine, Department of Gynecology and Obstetrics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshidakonoechou, Sakyouku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岩手医科大学附属病院（岩手県）、静岡県立総合病院（静岡県）、大津赤十字病院（滋賀県）、独立行政法人国立病院機構 京都医療センター（京都府）、近畿大学病院（大阪府）、公益財団法人田附興風会 医学研究所 北野病院（北野病院）、独立行政法人国立病院機構 大阪医療センター（大阪府）大阪赤十字病院（大阪府）、神戸市立医療センター 中央市民病院（兵庫県）兵庫県立尼崎総合医療センター（兵庫県）、日本赤十字社和歌山医療センター （和歌山県）、公益財団法人大原記念倉敷中央医療機構 倉敷中央病院 （岡山県）、高松赤十字病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39779654/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39779654/
Number of participants that the trial has enrolled
237
Results
Elevated NLR, PLR, and MLR were associated with poorer progression-free survival (PFS) in UCS. Additionally, a high NLR also indicated worse overall survival (OS) in UCS. In patients with US, only PLR was significantly associated with poorer PFS. Combining SIR indicators provided a stronger prognostic prediction for UCS compared to individual indicators. Multivariate analysis revealed that high levels of SIR indicators were an independent poor prognostic factor for both PFS and OS in UCS.
Results date posted
| 2025 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cases diagnosed with uterine carcinosarcoma or mesenchymal tumors at our hospital between January 2008 and December 2017 that met the inclusion criteria for this study.
Participant flow
We retrospectively reviewed the cases.
Adverse events
None
Outcome measures
Overall survivals, Proguression free survivals
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective observational is carried out on patient recordings that exist befor the start of this research. We include the patients who meet eligibility criteria and collect the information.
<contents collected>
age, performance status(PS), presence of menopausal, complications, estimated stage, histopatholgical findings(tissue type, lympho node metastasis, lymphovascular invasion, mitotic index, necrosis), size of the tumor, treatment(contents of chemotherapy, surgical procedure), laboratory paramater(tumor marker, blood cell count, AST,ALT,Alb, T-chol, LDL-chol, HDL-chol, TG, CRP etc.), outcome
Management information
Registered date
| 2021 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052036
