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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034995
Receipt No. 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 2018/11/26

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Basic information
Public title A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome
Acronym A Safety Evaluation of RRM for HBOC
Scientific Title A Safety Evaluation of Risk Reducing Mastectomy for Hereditary Breast and Ovarian Cancer Syndrome
Scientific Title:Acronym A Safety Evaluation of RRM for HBOC
Region
Japan

Condition
Condition Hereditary Breast and Ovarian Cancer Syndrome
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore safety of RRM for HBOC
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of complications related RRM within 3 months.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Surgery: Risk Reducing Mastectomy
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
80 years-old >=
Gender Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Goro Kutomi
Organization Sapporo Medical University Hospital
Division name Surgery, Surgical Oncology and Science
Zip code
Address S1, W16, Chuo-ku, Sapporo
TEL 011-611-2111
Email kutomi@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Shima
Organization Sapporo Medical University Hospital
Division name Surgery, Surgical Oncology and Science
Zip code
Address S1, W16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email simahiro@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University Hospital
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2018 Year 11 Month 26 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039895

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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