UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052526 |
|---|---|
| Receipt number | R000059881 |
| Scientific Title | A biomarker study using tumor-infiltrating lymphocytes in patienst with biliary tract cancer |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2024/04/17 10:39:55 |
* 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
A biomarker study using tumor-infiltrating lymphocytes in patienst with biliary tract cancer
Acronym
A biomarker study in biliary tract cancer
Scientific Title
A biomarker study using tumor-infiltrating lymphocytes in patienst with biliary tract cancer
Scientific Title:Acronym
A biomarker study in biliary tract cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To development new biomarkers for predicting efficacy and cancer immunotherapy from immunoprofiling of patients with biliary tract cancer
Basic objectives2
Others
Basic objectives -Others
To development new biomarkers for predicting efficacy and cancer immunotherapy from immunoprofiling by tumor-infiltrating lymphocyte (TIL) analyses in patients with biliary tract cancer
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression of CD4, CD8, FoxP3, CD25, CD45RA, CTLA-4, PD-1, ICOS, BTLA, Tim-3, LAG3, TIGIT, CD39, CD103, CD106, CCR7, CXCR5 and others in TILs evaluated by flow cytometry and/or immunostaining
Key secondary outcomes
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
Male and Female
Key inclusion criteria
1. Patients who were diagnosed with biliary tract cancer and treated at Okayama University Hospital since January 2014
2. There are sufficient residual specimens collected by biopsy or other means
3. Patients who have not refused to participate in the study
Key exclusion criteria
1. The sample volume does not remain
2. Under 20 years of age at the time of consent
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Togashi |
Organization
Okayama University
Division name
Department of Tumor Microenvironment, Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7390
ytogashi@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Togashi |
Organization
Okayama University
Division name
Department of Tumor Microenvironment, Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7390
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 Ethics Comitee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient accumulation in progress
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059881
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
