Unique ID issued by UMIN | UMIN000038229 |
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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 |
Evaluation of genetic counseling for disclosure of research-identified genetic mutations in breast cancer patients: a multicenter prospective observational cohort study
Evaluation of genetic counseling for disclosure of research-identified genetic mutations
Evaluation of genetic counseling for disclosure of research-identified genetic mutations in breast cancer patients: a multicenter prospective observational cohort study
Evaluation of genetic counseling for disclosure of research-identified genetic mutations
Japan |
Breast cancer
Breast surgery |
Malignancy
YES
identify their requirements based on assessment of genetic counseling for disclosure of research-identified genetic mutations through an established questionnaire completed by the clients
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
The change in GCOS-24 score between before and after genetic counseling (GCOS-24:The Genetic Counseling Outcome Scale)
Associations between the changes in GCOS-24 scores and patient factors
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
150
1st name | Nobuko |
Middle name | |
Last name | Kawaguchi-Sakita |
Kyoto University Hospital
Clinical Oncology
606-8507
54 Shogoin Kawara-cho Sakyo-ku, Kyoto
075-751-3660
nobuko75@kuhp.kyoto-u.ac.jp
1st name | Nobuko |
Middle name | |
Last name | Kawaguchi-Sakita |
Kyoto University Hospital
Clinical Oncology
606-8507
54 Shogoin Kawara-cho Sakyo-ku, Kyoto
075-751-3660
nobuko75@kuhp.kyoto-u.ac.jp
Kyoto University
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
Japan
Kyoto university Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committe
Yoshidakonoe-cho Sakyo-ku, Kyoto
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
YES
122
Japan Breast Cancer Society
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)
2019 | Year | 10 | Month | 08 | Day |
Unpublished
Main results already published
2017 | Year | 11 | Month | 30 | Day |
2017 | Year | 11 | Month | 30 | Day |
2017 | Year | 12 | Month | 20 | Day |
2022 | Year | 07 | Month | 20 | Day |
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.
2019 | Year | 10 | Month | 07 | Day |
2023 | Year | 10 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043551
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