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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038229
Receipt No. R000043551
Scientific Title Evaluation of genetic counseling for disclosure of research-identified genetic mutations in breast cancer patients: a multicenter prospective observational cohort study
Date of disclosure of the study information 2019/10/08
Last modified on 2019/10/07

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Basic information
Public title Evaluation of genetic counseling for disclosure of research-identified genetic mutations in breast cancer patients: a multicenter prospective observational cohort study
Acronym Evaluation of genetic counseling for disclosure of research-identified genetic mutations
Scientific Title Evaluation of genetic counseling for disclosure of research-identified genetic mutations in breast cancer patients: a multicenter prospective observational cohort study
Scientific Title:Acronym Evaluation of genetic counseling for disclosure of research-identified genetic mutations
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 identify their requirements based on assessment of genetic counseling for disclosure of research-identified genetic mutations through an established questionnaire completed by the clients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change in GCOS-24 score between before and after genetic counseling (GCOS-24:The Genetic Counseling Outcome Scale)
Key secondary outcomes Associations between the changes in GCOS-24 scores and patient factors

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following
1. Diagnosis as a carrier of a clinically actionable germline pathogenic/likely pathogenic genetic mutation (BRCA1, BRCA2, ATM, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, STK11, TP53, BRIP1, MSH2, MLH1, MSH6, PMS2, EPCAM, RAD51C, RAD51D, RYR2, RB1)in the previous study(Kyoto University Ethical Committe G424)
2. Regular follow-up in the participating hospitals
3. Consent to disclosure of the research results, genetic counseling and this study
Key exclusion criteria Patients who meet one of the following
1. Lost to follow-up
2. Declining disclosure of the research results, genetic counseling, or participation in this study
3. Previous genetic counseling and diagnosis as a carrier on clinical genetic testing
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Nobuko
Middle name
Last name Kawaguchi-Sakita
Organization Kyoto University Hospital
Division name Clinical Oncology
Zip code 606-8507
Address 54 Shogoin Kawara-cho Sakyo-ku, Kyoto
TEL 075-751-3660
Email nobuko75@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Nobuko
Middle name
Last name Kawaguchi-Sakita
Organization Kyoto University Hospital
Division name Clinical Oncology
Zip code 606-8507
Address 54 Shogoin Kawara-cho Sakyo-ku, Kyoto
TEL 075-751-3660
Homepage URL
Email nobuko75@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
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)

IRB Contact (For public release)
Organization Kyoto university Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committe
Address Yoshidakonoe-cho Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 122
Org. issuing International ID_1 Japan Breast Cancer Society
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 公益財団法人 田附興風会 医学研究所 北野病院(大阪府)
日本赤十字社 大阪赤十字病院(大阪府)
今井会足立病院 京都ブレストセンター 沢井記念乳腺クリニック(京都府)
地域医療機能推進機構 大和郡山病院(奈良県)
国家公務員共済組合連合会 枚方公済病院(大阪府)
医療法人神鋼会 神鋼病院(兵庫県)
京都市立病院(京都府)
地方独立行政法人 神戸市民病院機構 神戸市立医療センター中央市民病院(兵庫県)
大和高田市立病院(奈良県)
日本赤十字社和歌山医療センター(和歌山県)
滋賀県立総合病院(滋賀県)
兵庫県立尼崎総合医療センター(兵庫県)
菅典道クリニック(京都府)
大津市民病院(滋賀県)
洛和会音羽病院(京都府)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 08 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
2017 Year 11 Month 30 Day
Date of IRB
2017 Year 11 Month 30 Day
Anticipated trial start date
2017 Year 12 Month 20 Day
Last follow-up date
2022 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Based on assessment of genetic counseling for disclosure of research-identified genetic mutations through an established questionnaire completed by the clients,their requirements will be identified.

Management information
Registered date
2019 Year 10 Month 07 Day
Last modified on
2019 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043551

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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