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.
1. To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying BRCA1/2 variants. 2. To investigate risk factors concerning the development of ovarian, fallopian tube, and peritoneal cancers (loci of BRCA1/2 genetic variants, modifier genes, genetic polymorphism, hormones, and lifestyle habits.) in women carrying BRCA1/2 variants. 3. To estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (RRSO). 4. To examine the risk-reducing effect of RRSO on the development of ovarian, fallopian tube, and peritoneal cancers in women carrying BRCA1/2 variants, and compare with those not undergoing RRSO. 5. To identify clinicopathological features in women carrying BRCA1/2 variants who had undergone RRSO. 6. To identify the appropriate interval or degree of surveillance.
Study Type
OBSERVATIONAL
Enrollment
600
Okayama University
Okayama, Japan
RECRUITINGOccurrence of ovarian, fallopian tube, and peritoneal carcinoma
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct
Time frame: up to 15 years
Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.
Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct. The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.
Time frame: up to 15 years
Death from any cause
Death from any cause is a duration from the date of enrollment to the date of death from any cause. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct.
Time frame: up to 15 years
Deaths from ovarian, fallopian tube, and peritoneal cancers.
Deaths from ovarian, fallopian tube, and peritoneal cancers is a duration from the date of enrollment to the date of death from these cancers. If the subjects have undergone RRSO, the term is defined from the date of enrollment to the date of RRSO undergone.
Time frame: up to 15 years
Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.
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The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.
Time frame: up to 15 years
Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period.
Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal cancer, including in the post-RRSO period.
Time frame: up to 15 years
Death from any cause, including post-RRSO period.
Death from any cause, including post-RRSO period is a duration from the date of enrollment to the date of death from any cause, including in the post-RRSO period.
Time frame: up to 15 years