UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023533 |
|---|---|
| Receipt number | R000027043 |
| Scientific Title | Establishment of a genetic counseling model of genetic tests with use of multi-gene panels for hereditary tumor diseases Ver.1 |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2016/08/08 00:12:11 |
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Basic information
Public title
Establishment of a genetic counseling model of genetic tests with use of multi-gene panels for hereditary tumor diseases Ver.1
Acronym
Counseling model of genetic tests using multi-gene panels
Scientific Title
Establishment of a genetic counseling model of genetic tests with use of multi-gene panels for hereditary tumor diseases Ver.1
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Akira Yamauchi |
Organization
Kitano Hospital
Division name
Department of Breast Surgery
Zip code
Address
2-4-20, Ogimachi, Kitaku, Osaka Japan
TEL
06-6312-1221
a-yamauti@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamauchi |
Organization
Kitano Hospital
Division name
Department of Breast Surgery
Zip code
Address
2-4-20, Ogimachi, Kitaku, Osaka Japan
TEL
+81663121221
Homepage URL
http://www.kitano-hp.or.jp/
a-yamauti@kitano-hp.or.jp
Sponsor or person
Institute
Department of Breast Surgery, Kitano Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 07 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027043
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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