UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061689 |
|---|---|
| Receipt number | R000070580 |
| Scientific Title | A Retrospective Analysis of ADC Target Antigen Expression Profiles and Their Prognostic Significance in Endometrial Cancer |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/26 10:09:49 |
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Basic information
Public title
A Retrospective Analysis of ADC Target Antigen Expression Profiles and Their Prognostic Significance in Endometrial Cancer
Acronym
A Retrospective Analysis of ADC Target Antigen Expression Profiles and Their Prognostic Significance in Endometrial Cancer
Scientific Title
A Retrospective Analysis of ADC Target Antigen Expression Profiles and Their Prognostic Significance in Endometrial Cancer
Scientific Title:Acronym
A Retrospective Analysis of ADC Target Antigen Expression Profiles and Their Prognostic Significance in Endometrial Cancer
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to comprehensively analyze the expression of ADC target antigens, including HER2, TROP2, B7-H4, FRalpha, CDH6, HER3, and B7-H3, and their associations with hormone receptor status, including estrogen receptor and progesterone receptor expression, and PD-L1 expression.
Furthermore, this study aims to clarify the relationships between these biomarker expression profiles and clinicopathological factors, molecular characteristics, and prognosis, and to explore their potential utility as therapeutic targets and prognostic biomarkers for personalized medicine, as well as the potential for combination treatment strategies involving ADCs, hormone therapy, and immunotherapy.
Basic objectives2
Others
Basic objectives -Others
Others / Exploratory / Prognostic factor analysis / Biomarker study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between the expression of each biomarker and overall survival in patients with endometrial cancer who received initial treatment.
Key secondary outcomes
To evaluate the association between individual biomarker expression and progression-free survival.
To analyze the correlations between ADC target antigen expression and hormone receptor and PD-L1 expression.
To explore biomarker co-expression patterns to assess the potential for combination treatment strategies involving ADCs, hormone therapy, and immunotherapy.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients who are currently attending or have previously attended National Cancer Center Hospital East, National Cancer Center, Japan.
2. Patients for whom new comprehensive consent for the use of biobank specimens has been obtained.
3. Patients who were 18 years of age or older at the time of obtaining comprehensive consent.
4. Patients who were histologically diagnosed with stage III or IV endometrial cancer at our hospital between April 1, 2018 and December 31, 2025, and who received initial treatment, or patients with recurrent endometrial cancer.
5. Patients for whom formalin-fixed paraffin-embedded block specimens from surgical or biopsy samples are stored at our hospital.
Key exclusion criteria
1. Cases with insufficient specimens available for the study.
2. Cases in which only cytological examination was performed and histological diagnosis was not confirmed.
3. Cases in which study information was disclosed through an opt-out process and the patient refused to participate in the study.
4. Other cases deemed inappropriate by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Harano |
Organization
National Cancer Center Hospital East
Division name
Department of Medical Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL
04-7133-1111
haranokenichi@gmail.com
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Tsuchimochi |
Organization
National Cancer Center Hospital East
Division name
Department of Medical Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL
04-7133-1111
Homepage URL
stsuchim@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
Tel
04-7133-1111
ncc@esct.bvits.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information: Age, medical history, pathological diagnosis, treatment history, and clinical course, including recurrence and death, etc.
Samples: Residual surgical or biopsy specimens obtained for clinical purposes.
Management information
Registered date
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070580
