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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046081
Receipt No. R000052603
Scientific Title Clinicopathological significance of Alpha-2-glycoprotein 1 expression in triple-negative breast cancer
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/16

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Basic information
Public title Clinicopathological significance of Alpha-2-glycoprotein 1 expression in triple-negative breast cancer
Acronym Significance of Alpha-2-glycoprotein 1 expression in breast cancer
Scientific Title Clinicopathological significance of Alpha-2-glycoprotein 1 expression in triple-negative breast cancer
Scientific Title:Acronym Significance of Alpha-2-glycoprotein 1 expression in breast cancer
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the clinical significance of Zinc-alpha 2-Glycoprotein1 (ZAG) expression in triple-negative breast cancer, especially its efficacy as a predictive factor of response to preoperative chemotherapy (NAC).
Basic objectives2 Others
Basic objectives -Others To verify the efficacy of ZAG as a predictive factor of response to NAC.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Percentage of post-NAC pathological complete response (pCR rate) according to ZAG expression in pre-NAC primary lesions
Key secondary outcomes Correlation of ZAG expression and Androgen receptor (AR) in pre-NAC primary lesions
Correlation between ZAG expression and various immune markers (TIL, PDL-1) in pre-NAC primary lesions
Relationship between ZAG expression in the pre-NAC primary lesion and various clinical pathological findings including prognosis
Changes in ZAG, AR, Tumor Infiltrating Lymphocytes (TIL), and PDL-1 in breast cancer tissue before and after NAC
Differences in the clinical pathological significance of ZAG with and without expression of prolactin inducible protein (PIP)

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 Triple-negative breast cancer (TNBC) patients who underwent initial histological diagnosis of breast cancer at Tokai University Hospital and who underwent surgery for breast cancer after preoperative chemotherapy (NAC)
Key exclusion criteria 1) Under 20 years old
2) Bilateral breast cancer regardless of whether it is metachronous or simultaneous.
3) Cases with biopsy before NAC performed at institute other than Tokai University hospital.
4) Cases who underwent surgery after NAC outside the Tokai University hospital.
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 Oncology
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 Hanamura
Last name Hanamura
Organization Tokai University School of Medicine
Division name Department of Breast Oncology
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 Self funding
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 Board
Address 143 Shimokasuya, Isehara-shi, Kanagawa
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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
2021 Year 12 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
2021 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2021 Year 11 Month 16 Day
Last modified on
2021 Year 11 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052603

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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