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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040836
Receipt No. 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 2020/06/20

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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
Email 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
Email hanamura.toru.w@tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

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
Email 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
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
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
2022 Year 09 Month 30 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
2020 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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