An observational study in BRCA Mutation, Serous Tubal Intraepithelial Carcinoma and Ovarian Carcinoma, sponsored by Radboud University Medical Center. Not yet recruiting. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Radboud University Medical Center · Observational
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 600 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
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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.
Exclusion Criteria:
Women with isolated STIC diagnosed between 2015 and the start of the study.
Other: No intervention, only registration
Women with a newly diagnosed isolated STIC
Other: No intervention, only registration
No intervention, only registration
The risk for peritoneal carcinomatosis in women with isolated STIC
Time frame: 10 years
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
Histopathological characteristics
Identification of histopathological characteristics of STIC which are reproducible and associated to the risk of PC.
Time frame: 5-10 years
Additional diagnostics
To report findings at additional diagnostics (ie. imaging, staging surgery, CA125).
Time frame: 3 months
No study locations are listed for this record.
Plan to share: Yes — In collaboration with participating centers upon reasonable request.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center