Serous Endometrial Intraepithalial CarcinomaSEICNCT06677242
Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study
An observational study of Serous Endometrial Intraepithalial Carcinoma and SEIC, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Serous Endometrial Intraepithalial Carcinoma, SEIC
- What is being tested?
- Blood sample (serum) for circulating tumor DNA and cervical smear for genome-wide methylation sequencing
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2025to 1 Apr 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with serous endometrial intra-epithelial carcinoma
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045PM
Ward Hofhuis, +31104616161, w.hofhuis@franciscus.nl
About this study
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.
Read more
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
- Serous Endometrial Intraepithalial Carcinoma, SEIC
- Being tested
- Blood sample (serum) for circulating tumor DNA and cervical smear for genome-wide methylation sequencing
- Keywords
- Sereus endometrial intraepithelial carcinoma, SEIC, Endometrial cancer, Premalignant neoplasms
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample (serum) for circulating tumor DNA and cervical smear for genome-wide methylation sequencingDiagnostic test
These are additional tests, added to the observational study to collect information on tumor characteristics and to pursue early detection of this diagnosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Survival without recurrence of endometrial neoplasm
Measured: 5 years
Secondary outcomes (3)
Overall survival
Measured: 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)
Measured: 5 years
Adverse events
Any adverse event related to the treatment of SEIC
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2035 (estimated)
- Study completion1 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Serous Endometrial Intraepithalial CarcinomaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciska Slaager, Erasmus Medical Center
- Investigators
- Heleen J. van Beekhuizen, Principal investigator, Erasmus Medical Center, Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677242
- Sponsor's protocol ID
- OZBS82.24252
- Acronym
- SEIC
- Status last verified
- Feb 2025
- First submitted
- 5 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Slaager 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.
PubMed 37130624Slaager 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.
PubMed 42567642