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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peritoneal Carcinoma; Ovarian Carcinoma; Serous Tubal Intraepithelial Carcinoma; BRCA Mutation
• Intervention / Treatment: Other: No intervention, only registration

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Miranda Steenbeek, MD PhD; Phone Number: 0031615909405; Email: miranda.steenbeek@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

For the retrospective cohort: All women with STIC diagnosed between 2015 and start of the prospective study are identified. Data up until that time-point will be collected. At the end of the data collection follow-up will be updated on the women in the retrospective cohort.

For the prospective cohort: All consecutive women with isolated STIC from participating centres are informed on the study and requested to participate.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective cohort; Women with isolated STIC diagnosed between 2015 and the start of the study.	Other: No intervention, only registration; No intervention, only registration
Prospective cohort; Women with a newly diagnosed isolated STIC	Other: No intervention, only registration; No intervention, only registration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The risk for peritoneal carcinomatosis in women with isolated STIC	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors	Risk for PC in relation to patient characteristics such as age at diagnosis and presence of a genetic pathogenic variant.	5-10 years
Histopathological characteristics	Identification of histopathological characteristics of STIC which are reproducible and associated to the risk of PC.	5-10 years
Additional diagnostics	To report findings at additional diagnostics (ie. imaging, staging surgery, CA125).	3 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Digestive System Neoplasms; Abdominal Neoplasms; Carcinoma in Situ; Carcinoma; Peritoneal Neoplasms
• Other Study ID Numbers: 2024-17277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In collaboration with participating centers upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No