UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060677 |
|---|---|
| Receipt number | R000069402 |
| Scientific Title | Characterization of tumor-infiltrating lymphocytes (TILs) in endometrial cancer |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/15 09:33:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Immune Analysis of Endometrial Cancer
Acronym
IA-EC
Scientific Title
Characterization of tumor-infiltrating lymphocytes (TILs) in endometrial cancer
Scientific Title:Acronym
TIL-EC
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to characterize tumor-infiltrating lymphocytes (TILs) in patients with endometrial cancer, including the impact of reagents on their immunological profiles.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to elucidate the detailed immunological profiles of tumor-infiltrating lymphocytes (TILs) in endometrial cancer. Furthermore, the study aims to evaluate the impact of pharmacological agents on these immune cells through ex vivo cultivation and drug sensitivity assays.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Flow cytometric analysis of TILs
Key secondary outcomes
1. Protein analysis of TIL culture supernatants via ELISA and other methods
2. Immunohistochemical analysis of tumor tissues
3. Flow cytometric analysis of PBMCs and body cavity fluids
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 visit the institution between the date of approval by the head of the research institution and March 31, 2027.
2. Patients with a diagnosis or radiological suspicion of endometrial cancer, who are in good general condition and scheduled for tissue collection, such as via surgical resection.
3. Patients from whom written informed consent for study participation can be obtained based on their own free will.
4. Patients aged 18 years or older at the time of providing consent. No upper age limit is set as long as criterion 4 is met.
Key exclusion criteria
1. Women who are pregnant or may be pregnant.
2. Patients judged by their primary physician to be unsuitable for tissue collection or study participation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Togashi |
Organization
Okayama University
Division name
Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357390
ytogashi@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Togashi |
Organization
Okayama University
Division name
Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357390
Homepage URL
ytogashi@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Yosuke Togashi
Funding Source
Organization
Astrazeneca K.K.
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
OKAYAMA UNIVERSITY HOSPITAL
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862356938
mae6605@adm.okayama-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
岡山県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before start
Management information
Registered date
| 2026 | Year | 02 | Month | 15 | Day |
Last modified on
| 2026 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069402
