No intervention, only registration
OtherNo intervention, only registration
NCT Number: NCT06393543
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.
Trial opening soon.
Get Notified18 year–100 year
Female
Observational
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 27.5% (95% CI, 15.6-43.9) 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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention, only registration
Time frame: 10 years
Time frame: 5-10 years
Risk for PC in relation to patient characteristics such as age at diagnosis and presence of a genetic pathogenic variant.
Time frame: 5-10 years
Identification of histopathological characteristics of STIC which are reproducible and associated to the risk of PC.
Time frame: 3 months
To report findings at additional diagnostics (ie. imaging, staging surgery, CA125).
Contact information is provided by the study sponsor or research team.
Radboud University Medical Center
Other
Acronym: STICRISC
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