Unique ID issued by UMIN | UMIN000034995 |
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Receipt number | R000039895 |
Scientific Title | A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome |
Date of disclosure of the study information | 2018/11/26 |
Last modified on | 2019/11/27 12:56:44 |
A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome
A Safety Evaluation of RRM for HBOC
A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome
A Safety Evaluation of RRM for HBOC
Japan |
Hereditary Breast and Ovarian Cancer Syndrome
Breast surgery |
Malignancy
YES
To explore safety of RRM for HBOC
Safety
Confirmatory
Not applicable
Incidence of complications related RRM within 3 months.
Clinico-pathological characteristics and patients' background of primary breast cancer resected by RRM
Incidence and histological characteristics of occult breast cancer for RRM.
Exploratory outcome: Incidence of local recurrence and metastatic sites.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
1
Prevention
Maneuver |
Surgery: Risk Reducing Mastectomy
20 | years-old | <= |
80 | years-old | >= |
Female
A woman diagnosed has a BRCA1 or BRCA2 mutation, without breast cancer occurrence.
Performance status (ECOG scale): 0-2
Duration of survival is expected more than 3 months.
Written informed consent.
The presence of other active cancers (synchronous double cancers or metachronous double cancers required interventions).
The presence of severe symptomatic diseases or active infectious disease.
Physicians concludes that the patient participation on this study is inappropriate.
10
1st name | Goro |
Middle name | |
Last name | Kutomi |
Sapporo Medical University Hospital
Surgery, Surgical Oncology and Science
060-8543
S1, W16, Chuo-ku, Sapporo
011-611-2111
kutomi@sapmed.ac.jp
1st name | Hiroaki |
Middle name | |
Last name | Shima |
Sapporo Medical University Hospital
Surgery, Surgical Oncology and Science
060-8543
S1, W16, Chuo-ku, Sapporo
011-611-2111
simahiro@sapmed.ac.jp
Sapporo Medical University Hospital
none
Self funding
Sapporo Medical University
S1, W16, Chuo-ku, Sapporo
011-611-2111(31460)
simahiro@sapmed.ac.jp
NO
2018 | Year | 11 | Month | 26 | Day |
Unpublished
Open public recruiting
2018 | Year | 11 | Month | 08 | Day |
2018 | Year | 11 | Month | 26 | Day |
2018 | Year | 11 | Month | 26 | Day |
2019 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039895
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