An observational study in Serous Endometrial Intraepithalial Carcinoma and SEIC, sponsored by Erasmus Medical Center. Not yet recruiting at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Erasmus Medical Center · Observational
Background: Serous endometrial intra-epithelial carcinoma (SEIC) is a rare condition affecting the lining of the uterus. It's a pre-cancerous change that might lead to cancer if not treated. Doctors aren't sure of the best way to manage it because it's so uncommon. A previous study looked at past cases in the Netherlands from 2012 to 2020. This study found that none of the 23 women with SEIC had their cancer spread during surgery, and none had a recurrence in the following three years. This suggests that a simpler surgery might be safe for patients with SEIC.
Methods: Information on disease details from patients who agree to participate in our study will be collected. All participants will fill out online forms and health questionnaires at several points: when they join the study, and again at six months, two years, and five years after their diagnosis. During the years after diagnosis, various details like health status, test results, treatments will be checked in the electronic medical record.
Results: This study is just starting, with the first patients expected to join on January 1, 2025.
Conclusion: A large international study is created to track SEIC patients over time. This will help us learn more about the condition and improve treatment strategies.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 100 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with serous endometrial intra-epithelial carcinoma
Exclusion Criteria:
These are additional tests, added to the observational study to collect information on tumor characteristics and to pursue early detection of this diagnosis.
Progression-free survival
Survival without recurrence of endometrial neoplasm
Time frame: 5 years
Overall survival
Time frame: 5 years
Health-related quality of life
Assessed through EORTC questionnaires Assessed through three different questionnaires: EORTC-QLQ-C30 + QLQ-EN24 (together a total of 54 multiple-choice questions with a scale of 1-4 of severity of complaints) and EQ-5D-5L (multiple-choice, scale of severity, all different items will be entered in the digital database)
Time frame: 5 years
Adverse events
Any adverse event related to the treatment of SEIC
Time frame: 5 years
Plan to share: Undecided
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center