International Registration of Isolated STIC: to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention, only registration.
- Who it may be relevant to
- Registry conditions: BRCA Mutation, Serous Tubal Intraepithelial Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other No intervention, only registration
No intervention, only registration
Primary outcome measures
- The risk for peritoneal carcinomatosis in women with isolated STIC [Time frame: 10 years]
Secondary outcome measures (3)
- Risk factors [Time frame: 5-10 years]
- Histopathological characteristics [Time frame: 5-10 years]
- Additional diagnostics [Time frame: 3 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06393543 · 2024-17277