NCT03296826 Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
| NCT ID | NCT03296826 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
| Condition | BRCA1 and/or BRCA2 Variant Carriers |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2017-11-08 |
| Primary Completion | 2032-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2017-11-08 with a primary completion date of 2032-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2 variants.
Eligibility Criteria
Inclusion Criteria: 1. Women carrying BRCA1/2 variants (those with either BRCA1 or BRCA2 variants, or those carrying both variants) and women carrying a variant of uncertain significance (VUS). 2. Women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study. 3. Women who provide consent should be 20 years of age or older. 4. Women who provide written consent. Exclusion Criteria: 1. Women without ovarian or fallopian tube cancer at the time of informed consent. 2. Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development. 3. Other individuals considered inappropriate for involvement in this study by the investigator.
Contact & Investigator
Akira Hirasawa, M.D., Ph.D.
STUDY CHAIR
Okayama University
Frequently Asked Questions
Who can join the NCT03296826 clinical trial?
This trial is open to female participants only, aged 20 Years or older, studying BRCA1 and/or BRCA2 Variant Carriers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03296826 currently recruiting?
Yes, NCT03296826 is actively recruiting participants. Contact the research team at hir-aki45@umin.org for enrollment information.
Where is the NCT03296826 trial being conducted?
This trial is being conducted at Okayama, Japan.
Who is sponsoring the NCT03296826 clinical trial?
NCT03296826 is sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. The principal investigator is Akira Hirasawa, M.D., Ph.D. at Okayama University. The trial plans to enroll 600 participants.