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

NCT ID: NCT06393543

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2034-06-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Retrospective cohort

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

No intervention, only registration

Intervention Type: OTHER

No intervention, only registration

Prospective cohort

Women with a newly diagnosed isolated STIC

No intervention, only registration

Intervention Type: OTHER

No intervention, only registration

Interventions

No intervention, only registration

No intervention, only registration

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Miranda Steenbeek, MD PhD

Role: CONTACT

miranda.steenbeek@radboudumc.nl

0031615909405

Other Identifiers

2024-17277

Identifier Type: -

Identifier Source: org_study_id