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Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study

NCT06677242 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-02-10

No results posted yet for this study

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. 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

  • Serous Endometrial Intraepithalial Carcinoma
  • SEIC

Interventions

DIAGNOSTIC_TEST

Blood sample (serum) for circulating tumor DNA and cervical smear for genome-wide methylation sequencing

These are additional tests, added to the observational study to collect information on tumor characteristics and to pursue early detection of this diagnosis.

Sponsors & Collaborators

Principal Investigators

  • Heleen J. van Beekhuizen · Erasmus Medical Center, Cancer Institute

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2035-04-01
Completion
2035-04-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06677242 on ClinicalTrials.gov