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NCT06677242Not yet recruiting

Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study

Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
5 Nov 2024
Start date
1 Apr 2025
Primary completion date
1 Apr 2035
Lead sponsor
Erasmus Medical Center
NCT number
NCT06677242

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 Apr 2025 to the primary completion date, 1 Apr 2035
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous and/or current treatment for another malignancy (\<2 year before diagnosis of SEIC).

Other

  • Diagnosis with a different type of endometrial neoplasm or invasive carcinoma.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Franciscus Gasthuis & Vlietland
Coordinator of this site? Confirm its status
RotterdamNetherlandsUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.