BRCA Mutation, Ovarian Carcinoma, Peritoneal Carcinoma, Serous Tubal Intraepithelial Carcinoma
Conditions
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 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.
Interventions
OTHERNo intervention, only registration
No intervention, only registration
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Inclusion criteria
* Women * Bilateral salpingectomy (with or without oophorectomy) * A serous tubal intraepithelial carcinoma at histopathological review
Exclusion criteria
* Invasive cancer at initial surgery or pathological examination (either macroscopic and/or microscopic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The risk for peritoneal carcinomatosis in women with isolated STIC | 10 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors | 5-10 years | Risk for PC in relation to patient characteristics such as age at diagnosis and presence of a genetic pathogenic variant. |
| Histopathological characteristics | 5-10 years | Identification of histopathological characteristics of STIC which are reproducible and associated to the risk of PC. |
| Additional diagnostics | 3 months | To report findings at additional diagnostics (ie. imaging, staging surgery, CA125). |
Contacts
Primary ContactMiranda Steenbeek, MD PhD
Outcome results
None listed