UMIN ID: UMIN000054491
Registered date:01/06/2024
clinical trial of risk-reducing mastectomy (RRM) for BRCA1/2 gene mutation carriers
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Hereditary Breast and Ovarian Cancer |
| Date of first enrollment | 2024/06/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Perform a risk-reducing mastectomy if the patient requests it. |
Outcome(s)
| Primary Outcome | Safety of risk-reducing mastectomy (RRM) for BRCA1/2 gene mutation carriers Frequency of intraoperative and postoperative complications |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1) Surgery is not possible after normal preoperative examinations 2) Patients who are pregnant or may become pregnant 3) Patients who are judged by the research director or co-investigator to be unsuitable as research subjects |
Related Information
| Primary Sponsor | Mie University hospital, breast center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | scholarship donation for breast center |
| Secondary ID(s) | H2024-079 |
Contact
| public contact | |
| Name | Mao Kimoto |
| Address | Edobashi 2-174, Tsu City, Mie Pref, JAPAN Japan 5148507 |
| Telephone | 0592321111 |
| k-mao@med.mie-u.ac.jp | |
| Affiliation | Mie University hospital breast center |
| scientific contact | |
| Name | Kosuke Kawaguchi |
| Address | Edobashi 2-174, Tsu City, Mie Pref, JAPAN Japan |
| Telephone | 0592321111 |
| k-mao@med.mie-u.ac.jp | |
| Affiliation | Mie University hospital breast center |