UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040836 |
|---|---|
| Receipt number | R000046611 |
| Scientific Title | Elucidation of tumor immuno-regulatory mechanism via androgen receptor signal in breast cancer |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2022/12/22 09:08:03 |
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Basic information
Public title
Elucidation of tumor immuno-regulatory mechanism via androgen receptor signal in breast cancer
Acronym
Elucidation of tumor immuno-regulatory mechanism via androgen receptor signal in breast cancer
Scientific Title
Elucidation of tumor immuno-regulatory mechanism via androgen receptor signal in breast cancer
Scientific Title:Acronym
Elucidation of tumor immuno-regulatory mechanism via androgen receptor signal in breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we clarify the function of Alpha-2-glycoprotein 1, zinc-binding (ZAG) as a tumor immunoregulatory mechanism via androgen receptor (AR) signal in breast cancer.
Basic objectives2
Others
Basic objectives -Others
Single cell suspension is prepared from the tumor tissue collected from the primary breast cancer excision sample, and the sample is evaluated by multicolor flow cytometry and flow bead array to perform phenotypic analysis of intratumoral immune cells and cytokine quantification. Subsequently, AR, ZAG, AR, PD-L1 expression and tumor infiltrating immune cells (TILs) are evaluated by immunostaining in the same specimen. The correlation between ZAG, intratumoral immune cell composition, cytokine composition, expression of various immune checkpoint-related molecules, and TILs are analyzed.
The action of recombinant ZAG on primary immune cells or model cell lines, corresponding to immune cells considered to be the primary target of ZAG will be clarified by in-vtro study.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between ZAG, intratumoral immune cell composition, cytokine composition, expression of various immune checkpoint-related molecules, and TILs.
Key secondary outcomes
The action of recombinant ZAG on primary immune cells or model cell lines, corresponding to immune cells considered to be the primary target of ZAG.
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
1) Those with a definitive diagnosis of breast cancer obtained by needle biopsy.
2) No previous history of breast cancer treatment (for metachronous bilateral breast cancer, history of initial breast cancer is acceptable).
3) Estrogen receptor (ER) positive (>1%) and HER2 negative (score 1 or score 2 DISH negative)
4) Those who received sufficient explanation for participation in this research and obtained their written consent by their free will.
Key exclusion criteria
1) Age less than 20 years old.
2) Anyone or more of steroids, immunosuppressants, sex hormones, and endocrine therapeutics have been administered within the past 3 months.
3) Pathological conditions (primary immunodeficiency, HIV infection, hematological cancer (including past history)) that may be accompanied by abnormal systemic immune function.
4) Breast cancer diagnosed by incision biopsy.
5) Those with clear hematoma formation or infection after needle biopsy.
6) Those who received pre-operative drug therapy.
7) In case of insufficient tumor sample for routine pathological examination if sample are collectied for this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Hanamura |
Organization
Tokai University School of Medicine
Division name
Department of Breast and Endocrine Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
hanamura.toru.w@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Hanamura |
Organization
Tokai University School of Medicine
Division name
Department of Breast and Endocrine Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
Homepage URL
hanamura.toru.w@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
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
Tokai University School of Medicine Clinical Research Review Committee
Address
143 Shimokasuya, Isehara-shi, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
189
Org. issuing International ID_1
Japanese Breast Cancer Society
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | 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
45
Results
For 45 breast cancer clinical specimens, the number of tumor infiltrating leukocytes and the ratio of various immune cell fractions to them are measured by multicolor flow cytometry. AR and ZAG expression was quantified by immunostaining. AR expression showed a positive correlation with the proportions of NK cells and NKT cells, and ZAG expression showed an inverse correlation with the proportions with Monocytes (including Macrophage-like cells) and MDSC.
Results date posted
| 2021 | Year | 12 | Month | 22 | Day |
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2020 | Year | 06 | Month | 20 | Day |
Last modified on
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046611
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