Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study (SEIC)

February 6, 2025 updated by: Ciska Slaager, Erasmus Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3045PM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with serous endometrial intra-epithelial carcinoma

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 years
Survival without recurrence of endometrial neoplasm
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
5 years
Adverse events
Time Frame: 5 years
Any adverse event related to the treatment of SEIC
5 years
Health-related quality of life
Time Frame: 5 years
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)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Heleen J. van Beekhuizen, Erasmus Medical Center, Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 1, 2035

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OZBS82.24252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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