UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038229 |
|---|---|
| Receipt number | 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 | 2023/10/03 12:59:25 |
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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
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
nobuko75@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
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
Kyoto university Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committe
Address
Yoshidakonoe-cho Sakyo-ku, Kyoto
Tel
075-753-4680
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
Main results already published
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
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043551
