Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06393543

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention, only registration

Other

No intervention, only registration

Primary outcomes

  1. The risk for peritoneal carcinomatosis in women with isolated STIC

    Time frame: 10 years

Secondary outcomes

  1. Risk factors

    Time frame: 5-10 years

    Risk for PC in relation to patient characteristics such as age at diagnosis and presence of a genetic pathogenic variant.

  2. Histopathological characteristics

    Time frame: 5-10 years

    Identification of histopathological characteristics of STIC which are reproducible and associated to the risk of PC.

  3. Additional diagnostics

    Time frame: 3 months

    To report findings at additional diagnostics (ie. imaging, staging surgery, CA125).

Study contacts

Contact information is provided by the study sponsor or research team.

Miranda Steenbeek, MD PhD

CONTACT

[email protected]

0031615909405

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: STICRISC

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.