UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046996 |
|---|---|
| Receipt number | R000053578 |
| Scientific Title | Feasibility study of risk reducing mastectomy for Hereditary Breast and Ovarian cance |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/02/24 19:59:00 |
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Basic information
Public title
Feasibility study of risk reducing mastectomy for Hereditary Breast and Ovarian cancer
Acronym
Feasibility study of RRM for HBOC
Scientific Title
Feasibility study of risk reducing mastectomy for Hereditary Breast and Ovarian cance
Scientific Title:Acronym
Feasibility study of RRM for HBOC
Region
| Japan |
Condition
Condition
HBOC
Classification by specialty
| Breast surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Safetey assesment of RRM for HBOC
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of Surgery
Key secondary outcomes
Confirm the presence of breast cancer lesions in the resected mammary gland
Base
Study type
Others,meta-analysis etc
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 BRCA1 / 2 gene mutation-positive unilateral breast cancer patients with no suspected breast cancer in healthy breast and BRCA1 / 2 genetic mutation-positive unilateral breast cancer patients with no suspected breast cancer in contralateral healthy breast
2 The patient who has already been given genetic counseling
3 The patient who has been proven to have a BRCA1 or BRCA2 gene mutation
4 The patient with no suspicious findings of metastasis or recurrence of obvious breast cancer
5 Patients who understand risk-reducing mastectomy and wish to have risk-reducing mastectomy
7 The patient who retains the functions of major organs (bone marrow, heart, lungs, liver, kidneys, etc.)
1)White blood cells: 3000 / mm3 or more, less than 12,000 / mm3
2)Hemoglobin: 9.0 g / dl or more
3)Platelets: 100,000 / mm3 or more
4)Total bilirubin: less than 2.0 mg / dL
5)AST, ALT: Facility normal value upper limit x 2 or less
6))Serum creatinine: Within normal facility normal value x 1.5
7)ECG, vital capacity: Patients with cardiopulmonary function who can operate with general anesthesia
The inspection data in 1) -7) above shall be within 60 days before the date of consent acquisition.
8) Written consent from the subject to participate in this study
9) Women who are 20 years or older on the date of consent acquisition
Key exclusion criteria
1) The patient with cancer other than active primary early stage breast cancer (regardless of history of breast cancer or ovarian cancer)
2) Pregnant and lactating women
3) The patient with an infectious disease requiring systemic treatment
4) Bilateral breast cancer patients
5) The patient who the researcher deems inappropriate to participate in this study
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Maeda |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7550085
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
Homepage URL
nsampei@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate 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
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-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
山口大学大学院 消化器・腫瘍外科学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 11 | 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
Safety assessment of RRM for HBOC
Management information
Registered date
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053578
