Clinical trial · Observational
Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SEIC | Serous Endometrial Intraepithelial Carcinoma | ALIAS | 0.90 |
| Serous Endometrial Intraepithalial Carcinoma | Endometrial Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample (serum) for circulating tumor DNA and cervical smear for genome-wide methylation sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 5 years
- description
- Survival without recurrence of endometrial neoplasm
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- 5 years
- measure
- Health-related quality of life
- timeFrame
- 5 years
- description
- 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)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Serous endometrial intra-epithelial carcinoma (SEIC). * Women older than 18 years of age. * Women with understanding of Dutch or English language in reading and writing. Exclusion Criteria: * Diagnosis with a different type of endometrial neoplasm or invasive carcinoma. * Previous and/or current treatment for another malignancy (\<2 year before diagnosis of SEIC).
References
Publications (2)
- BACKGROUNDSlaager C, Hofhuis W, Hoogduin KJ, Ewing-Graham PC, van Beekhuizen HJ. Serous endometrial intra-epithelial carcinoma: an observational study. Int J Gynecol Cancer. 2023 Jun 5;33(6):905-914. doi: 10.1136/ijgc-2023-004281. PMID 37130624
- DERIVEDSlaager FC, Hoogduin KJ, Hofhuis W, Groenendijk FH, van Beekhuizen HJ. Intraepithelial serous carcinoma of the endometrium: protocol for a prospective multicentre registry in the Netherlands. BMJ Open. 2026 Aug 7;16(8):e120737. doi: 10.1136/bmjopen-2026-120737. PMID 42567642