Prospective Cohort Study of Germline Variant Carriers with BRCA1 or BRCA2

Launched by TRANSLATIONAL RESEARCH CENTER FOR MEDICAL INNOVATION, KOBE, HYOGO, JAPAN · Sep 27, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at women who carry specific genetic changes in the BRCA1 or BRCA2 genes to better understand how these changes might influence the risk of developing ovarian, fallopian tube, or peritoneal cancers. By studying these women, the researchers aim to find out how common these cancers are in this group and what factors might increase the risk of developing them. The study is currently recruiting participants, specifically women aged 20 and older who have been counseled about their genetic status and have a BRCA1 or BRCA2 variant, including those with a variant of uncertain significance.

To participate in this study, women must not currently have ovarian or fallopian tube cancers, and they should not have been diagnosed with these cancers in the past. Participants will be asked to provide written consent and will undergo assessments related to their genetic changes. Joining the study could help improve understanding of these cancers and may benefit future patients. If you think you might be eligible or want more information, it’s a good idea to discuss this with your healthcare provider.

Gender

FEMALE

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.