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 |
Feasibility study of risk reducing mastectomy for Hereditary Breast and Ovarian cancer
Feasibility study of RRM for HBOC
Feasibility study of risk reducing mastectomy for Hereditary Breast and Ovarian cance
Feasibility study of RRM for HBOC
Japan |
HBOC
Breast surgery |
Others
YES
Safetey assesment of RRM for HBOC
Safety
Safety of Surgery
Confirm the presence of breast cancer lesions in the resected mammary gland
Others,meta-analysis etc
20 | years-old | <= |
Not applicable |
Female
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
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
2
1st name | Hiroaki |
Middle name | |
Last name | Nagano |
Yamaguchi University Graduate School of Medicine
Department of Gastroenterological, Breast and Endocrine Surgery
755-8505
1-1-1 Minami-Kogushi, Ube, Yamaguchi
0836222264
hnagano@yamaguchi-u.ac.jp
1st name | Noriko |
Middle name | |
Last name | Maeda |
Yamaguchi University Graduate School of Medicine
Department of Gastroenterological, Breast and Endocrine Surgery
7550085
1-1-1 Minami-Kogushi, Ube, Yamaguchi
0836222264
nsampei@yamaguchi-u.ac.jp
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Self funding
Center For Clinical Research, Yamaguchi University Hospital
1-1-1 Minami-Kogushi, Ube, Yamaguchi
0836-22-2428
me223@yamaguchi-u.ac.jp
NO
山口大学大学院 消化器・腫瘍外科学
2022 | Year | 03 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 09 | Month | 20 | Day |
2019 | Year | 10 | Month | 23 | Day |
2019 | Year | 11 | Month | 01 | Day |
2024 | Year | 03 | Month | 31 | Day |
Safety assessment of RRM for HBOC
2022 | Year | 02 | Month | 24 | Day |
2022 | Year | 02 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053578