NCT06393543

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: —

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.

Conditions

• BRCA Mutation
• Serous Tubal Intraepithelial Carcinoma
• Ovarian Carcinoma
• Peritoneal Carcinoma

Interventions

Type	Name	Description
OTHER	No intervention, only registration	No intervention, only registration

Timeline

• Start date: 2024-06-01
• Primary completion: 2034-06-01
• Completion: 2034-06-01
• First posted: 2024-05-01
• Last updated: 2024-05-01