Ignite Creation Date:
2024-05-06 @ 10:34 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03296826
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2017-09-25
Brief Title:
Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
Sponsor:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Organization:
Translational Research Center for Medical Innovation Kobe Hyogo Japan
Study Overview
Official Title:
Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BRCA12 variants
Detailed Description:
1 To estimate the incidence of ovarian fallopian tube and peritoneal cancers in women carrying BRCA12 variants
2 To investigate risk factors concerning the development of ovarian fallopian tube and peritoneal cancers loci of BRCA12 genetic variants modifier genes genetic polymorphism hormones and lifestyle habits in women carrying BRCA12 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 BRCA12 variants and compare with those not undergoing RRSO
5 To identify clinicopathological features in women carrying BRCA12 variants who had undergone RRSO
6 To identify the appropriate interval or degree of surveillance
2 To investigate risk factors concerning the development of ovarian fallopian tube and peritoneal cancers loci of BRCA12 genetic variants modifier genes genetic polymorphism hormones and lifestyle habits in women carrying BRCA12 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 BRCA12 variants and compare with those not undergoing RRSO
5 To identify clinicopathological features in women carrying BRCA12 variants who had undergone RRSO
6 To identify the appropriate interval or degree of surveillance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMIN000028740 | REGISTRY | UMIN-CTR | None |