Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393543
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
International Registration of Isolated STIC to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
International Registration of Isolated STIC to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
STICRISC
Brief Summary:
To prospectively assess the incidence of peritoneal carcinomatosis for women with isolated STIC serous tubal intraepithelial carcinoma Moreover to identify histopathological characteristics of STIC which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of additional diagnostics
Detailed Description:
Women with a BRCA pathogenic variant PV undergo a risk-reducing salpingo-oophorectomy RRSO to reduce their ovarian cancer risk of 17-44 A residual risk for peritoneal cancer PC persists with most patients having extensive tumour spread throughout the abdomen Despite surgery and chemotherapy the five-year survival rate of PC is only 14-30 Recently it became apparent that PC is frequently preceded by a preinvasive serous tubal intraepithelial cancer STIC at RRSO The entity STIC is often found conjointly with ovarian cancer but can also be present as an isolated condition mostly in high risk women If this STIC is found at RRSO the risk for PC was found to be 275 95 CI 156-439 after ten years whilst this risk was 1 without STIC The pathophysiological mechanism of this association is not yet known and it is unknown which women with STIC are most at risk Moreover the additional value of diagnostics and management is unknown as data is lacking
Objective To prospectively assess the PC incidence for women with isolated STIC to identify histopathological characteristics of STIC which are reproducible and associated to the risk of PC and to report the findings of additional diagnostics
Objective To prospectively assess the PC incidence for women with isolated STIC to identify histopathological characteristics of STIC which are reproducible and associated to the risk of PC and to report the findings of additional diagnostics
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