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

Ovarian Carcinoma Clinical Trial

— STICRISC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393543
• Other study ID #: 2024-17277
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2034

Study information

• Verified date: April 2024
• Source: Radboud University Medical Center
• Contact: Miranda Steenbeek, MD PhD
• Phone: 0031615909405
• Email: miranda.steenbeek[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: June 2034
• Est. primary completion date: June 2034
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• BRCA Mutation
• Carcinoma
• Carcinoma in Situ
• Ovarian Carcinoma
• Peritoneal Carcinoma
• Peritoneal Neoplasms

Intervention

Other:
• No intervention, only registration
No intervention, only registration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The risk for peritoneal carcinomatosis in women with isolated STIC		10 years
Secondary	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
Secondary	Histopathological characteristics	Identification of histopathological characteristics of STIC which are reproducible and associated to the risk of PC.	5-10 years
Secondary	Additional diagnostics	To report findings at additional diagnostics (ie. imaging, staging surgery, CA125).	3 months