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

Not yet recruiting

• Conditions: BRCA Mutation; Serous Tubal Intraepithelial Carcinoma; Peritoneal Carcinoma; Ovarian Carcinoma
• Interventions: Other: No intervention, only registration

• Registration Number: NCT06393543
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-26
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Study Start: 2024-06
• Primary Completion: 2034-06
• Study Completion: 2034-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Women
• Bilateral salpingectomy (with or without oophorectomy)
• A serous tubal intraepithelial carcinoma at histopathological review

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Exclusion Criteria

• Invasive cancer at initial surgery or pathological examination (either macroscopic and/or microscopic)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective cohort	No intervention, only registration	Women with isolated STIC diagnosed between 2015 and the start of the study.
Prospective cohort	No intervention, only registration	Women with a newly diagnosed isolated STIC

Primary Outcome Measures

Name	Time	Method
The risk for peritoneal carcinomatosis in women with isolated STIC	10 years

Secondary Outcome Measures

Name	Time	Method
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).