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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Survival without recurrence of endometrial neoplasm | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years | |
| Health-related quality of life | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Only individuals with an uterus and endometrial disease are eligible.
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Women with serous endometrial intra-epithelial carcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ciska Slaager | Contact | +31652377107 | ciskaslaager@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Heleen J. van Beekhuizen | Erasmus Medical Center, Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franciscus Gasthuis & Vlietland | Rotterdam | South Holland | 3045PM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37130624 | Background | 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. |
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Blood serum for circulating tumor DNA and additional PAP-smear for genome-wide methylation sequencing.
| 5 years |
| Adverse events | Any adverse event related to the treatment of SEIC | 5 years |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014626 | Vaginal Smears |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
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