UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046081 |
|---|---|
| Receipt number | 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 | 2024/11/19 13:42:19 |
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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
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
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
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
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052603
