UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050985 |
|---|---|
| Receipt number | R000058114 |
| Scientific Title | Exploratory prospective clinical study on predictors of efficacy of immune checkpoint inhibitors and immune-related adverse events in early-stage breast cancer |
| Date of disclosure of the study information | 2023/05/10 |
| Last modified on | 2024/05/04 23:57:53 |
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Basic information
Public title
Exploratory prospective clinical study on predictors of efficacy of immune checkpoint inhibitors and immune-related adverse events in early-stage breast cancer
Acronym
Exploratory prospective clinical study on predictors of efficacy of immune checkpoint inhibitors and immune-related adverse events in early-stage breast cancer
Scientific Title
Exploratory prospective clinical study on predictors of efficacy of immune checkpoint inhibitors and immune-related adverse events in early-stage breast cancer
Scientific Title:Acronym
Exploratory prospective clinical study on predictors of efficacy of immune checkpoint inhibitors and immune-related adverse events in early-stage breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to identify predictors of immune checkpoint inhibitor efficacy and immune-related adverse events in early triple-negative breast cancer by assessing the tumor microenvironment and the patient's immune environment over time.
Basic objectives2
Others
Basic objectives -Others
To verify whether it is possible to predict pCR/irAE of ICI combination therapy in early TNBC from microbiome and breast cancer tissue.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To verify whether it is possible to predict the pCR and irAE of ICI combination therapy from microbiome in early-stage TNBC.
Key secondary outcomes
Presence or absence of changes in intestinal flora due to ICI administration
Relationship between microbiome and IOscore
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who are pathologically diagnosed with invasive breast cancer and are scheduled for Neoadjubant chemotherapy.
2) ER-negative, PgR-negative, and HER2-negative by histopathological examination.
3)Patients who gave written informed consent to participate in this study.
Key exclusion criteria
2) Patients who have not given consent to this study
3) Patients who also have other malignant tumors
4) Bilateral breast cancer
5) history of malignant tumor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hayashi |
Organization
Showa University
Division name
Department of Surgery, Division of Breast surgical oncology
Zip code
142-8555
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL
03-3784-8000
osau0310@gmail.com
Public contact
Name of contact person
| 1st name | Sayuka |
| Middle name | |
| Last name | Nakayama |
Organization
showa university
Division name
Department of Surgery, Division of Breast surgical oncology
Zip code
142-8555
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL
03-3784-8000
Homepage URL
osau0310@gmail.com
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
kitazato univerity hosputa
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa university
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-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 | 05 | Month | 10 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will distinguish between pCR and nonpCR, or the presence or absence of irAE expression.
We will evaluate the tumor microenvironment using breast cancer tissue specimens at diagnosis, during ICI treatment, and at surgery, and at the same time evaluate the patient's immune environment by microbiome.
Management information
Registered date
| 2023 | Year | 05 | Month | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058114
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
