UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of a genetic counseling model of genetic tests with use of multi-gene panels for hereditary tumor diseases Ver.1
Title of the study (Brief title)	Counseling model of genetic tests using multi-gene panels
Region	Japan

Condition
Condition	Hereditary tumor disease
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To validate a genetic counseling model of genetic tests for hereditary tumor clients who will undergo genetic tests with use of multi-gene panels by investigating the levels of hope for disclosure of the result
Basic objectives2	Others
Basic objectives -Others	To establish a genetic counseling model of genetic tests with use of multi-gene panels
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of clients who hope full disclosure of genetic tests with use of multi-gene panels
Key secondary outcomes	Time of counseling for clients who hope full disclosure of genetic tests with use of multi-gene panels

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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) Probands suspicious of hereditary tumor diseases or unaffected clients who desire genetic counseling and genetic tests. 2) Probands suspicious of hereditary tumor diseases or unaffected clients who desire multi-gene panel tests after informed of merits and demerits of multi-gene panel tests in this study
Key exclusion criteria	Except for above
Target sample size	30

Research contact person
Name of lead principal investigator	Akira Yamauchi
Organization	Kitano Hospital
Division name	Department of Breast Surgery
Address	2-4-20, Ogimachi, Kitaku, Osaka Japan
TEL	06-6312-1221
Email	a-yamauti@kitano-hp.or.jp

Public contact
Name of contact person	Akira Yamauchi
Organization	Kitano Hospital
Division name	Department of Breast Surgery
Address	2-4-20, Ogimachi, Kitaku, Osaka Japan
TEL	+81663121221
Homepage URL	http://www.kitano-hp.or.jp/
Email	a-yamauti@kitano-hp.or.jp

Sponsor
Institute	Department of Breast Surgery, Kitano Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	北野病院（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 07 Month 20 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Results of this study will be reported in scientific meetings or in journals without disclosure of clients' information.

Management information
Registered date	2016 Year 08 Month 08 Day
Last modified on	2016 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027043