UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058327 |
|---|---|
| Receipt number | R000066666 |
| Scientific Title | Holistic Analysis of Breast Cancer with BRCA1/2 Pathogenic Variants and Development of a Decision Aid for Risk-Reducing Mastectomy: BRCA-Decision study |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2025/06/30 23:10:22 |
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Basic information
Public title
Holistic Analysis of Breast Cancer with BRCA1/2 Pathogenic Variants and Development of a Decision Aid for Risk-Reducing Mastectomy: BRCA-Decision study
Acronym
BRCA-Decision study
Scientific Title
Holistic Analysis of Breast Cancer with BRCA1/2 Pathogenic Variants and Development of a Decision Aid for Risk-Reducing Mastectomy: BRCA-Decision study
Scientific Title:Acronym
BRCA-Decision study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to elucidate the differences in health-related quality of life (HR-QOL) and decision-making factors associated with the implementation of contralateral risk-reducing mastectomy (CRRM) in patients with breast cancer carrying BRCA1/2 pathogenic variants, and to develop a high-quality decision aid to support surgical choices.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of HR-QOL Between Patients With BRCA1/2 Pathogenic Variant-Associated Breast Cancer with or without CRRM
Key secondary outcomes
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. Female patients diagnosed with primary breast cancer who were confirmed to carry BRCA1/2 pathogenic variants through genetic testing between April 1, 2020, and June 30, 2026, and for whom at least three months have passed since the diagnosis
2. No restrictions regarding the type of breast surgery, presence or absence of breast reconstruction, or use of adjuvant therapy
3. Women aged 20 years or older
Key exclusion criteria
1. Patients with de novo stage IV breast cancer or with recurrent breast cancer
2. Patients with synchronous bilateral breast cancer
3. Patients with metachronous bilateral breast cancer who have previously undergone total mastectomy on either side
4. Individuals carrying BRCA1/2 pathogenic variants without a history of breast cancer
5. Patients with active malignant diseases other than occult ovarian or fallopian tube cancer identified through risk-reducing salpingo-oophorectomy (RRSO)
6. Patients with severe psychiatric disorders
7. Patients deemed unsuitable for participation by the attending physician
8. Patients who decline to participate in the study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Seki |
Organization
Kyorin University, School of Medicine
Division name
Breast Surgery
Zip code
181-8611
Address
6-20-2 Shinakwa Mitakashi, Tokyo
TEL
0422-47-5511
hirohito.seki@gmail.com
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Seki |
Organization
Kyorin University, School of Medicine
Division name
Breast Surgery
Zip code
181-8611
Address
6-20-2 Shinakwa Mitakashi, Tokyo
TEL
0422-47-5511
Homepage URL
hirohito.seki@gmail.com
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
other
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
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima, Japan
Tel
082-257-1551
iryo-sinsa@office.hiroshima-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
| 2026 | Year | 07 | 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
| 2025 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The questionnaire-based assessment will include the BREAST-Q, Decision Regret Scale (DRS), and Hospital Anxiety and Depression Scale (HADS).
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066666
