Clinical trial NCT06677242: Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study
Official title: Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Serous Endometrial Intraepithalial Carcinoma
SEIC
Keywords: Sereus endometrial intraepithelial carcinoma
SEIC
Endometrial cancer
Premalignant neoplasms
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with serous endometrial intra-epithelial carcinoma

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Health-related quality of life
timeFrame: 5 years
measure: Adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center, Cancer Institute
name: Heleen J. van Beekhuizen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.