International Registration of Isolated STIC: to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis (STICRISC)

Radboud University Medical Center

Status: Not yet enrolling

Conditions: BRCA Mutation; Ovarian Carcinoma; Serous Tubal Intraepithelial Carcinoma; Peritoneal Carcinoma

Treatments: Other: No intervention, only registration

Study type: Observational

Funder types: Other

Identifiers

NCT06393543

2024-17277

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

600 participants in 2 patient groups

Retrospective cohort

Description:

Women with isolated STIC diagnosed between 2015 and the start of the study.

Treatment:

Other: No intervention, only registration

Prospective cohort

Description:

Women with a newly diagnosed isolated STIC

Treatment:

Other: No intervention, only registration