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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-100
SponsorRadboud University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women

Bilateral salpingectomy (with or without oophorectomy)

A serous tubal intraepithelial carcinoma at histopathological review

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention, only registration

    Other intervention

    No intervention, only registration

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Retrospective cohort1 intervention
Group B: Prospective cohort1 intervention

Trial outcomes

Primary outcomes

1

The risk for peritoneal carcinomatosis in women with isolated STIC

Time frame
10 years

Secondary outcomes

1

Risk factors

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

Time frame
5-10 years
2

Histopathological characteristics

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

Time frame
5-10 years
3

Additional diagnostics

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

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: