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NCT Number: NCT06677242

Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Progression-free survival

    Time frame: 5 years

    Survival without recurrence of endometrial neoplasm

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

  2. 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)

  3. Adverse events

    Time frame: 5 years

    Any adverse event related to the treatment of SEIC

Study contacts

Contact information is provided by the study sponsor or research team.

Ciska Slaager

CONTACT

[email protected]

+31652377107

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: SEIC

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Nov 6, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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