Where does OCRA's clinical trial data come from?

OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

How do I find clinical trials for ovarian cancer?

Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

How often is clinical trial data updated?

Trial data is refreshed through periodic ingestion from the ClinicalTrials.gov v2 API. Status changes, new enrollments, and newly registered trials are captured during each update cycle.

Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study

NCT06677242NOT_YET_RECRUITINGOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Erasmus Medical Center

Enrollment

100

Start Date

2025-04-01

Completion Date

2035-04-01

Study Type

OBSERVATIONAL

Official Title

Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study

Interventions

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

Conditions

Serous Endometrial Intraepithalial CarcinomaSEIC

Eligibility

Age Range

18 Years+

Sex

FEMALE

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).

Outcome Measures

Primary Outcomes

Progression-free survival

Survival without recurrence of endometrial neoplasm

Time frame: 5 years

Secondary Outcomes

Overall survival

Time frame: 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)

Time frame: 5 years

Adverse events

Any adverse event related to the treatment of SEIC

Time frame: 5 years

Locations

Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands

Linked Papers

2023-06-05

Serous endometrial intra-epithelial carcinoma: an observational study

Serous endometrial intra-epithelial carcinoma is described as a malignant, superficial spreading lesion with risk of extra-uterine spread at time of diagnosis, and poor outcome. To evaluate the surgical management of patients with serous endometrial intra-epithelial carcinoma and its impact on oncologic outcomes and complications. This Dutch observational retrospective cohort study evaluated all patients diagnosed with pure serous endometrial intra-epithelial carcinoma in the Netherlands, between January 2012 and July 2020. The pathological examination was reviewed by two pathologists with expertise in gynecological oncology. Clinical data were obtained when the diagnosis was confirmed. Primary outcome is progression-free survival, secondary outcomes are duration of follow-up, adverse events related to surgery, and overall survival. A total of 23 patients from 13 medical centers were included, of whom 15 (65.2%) presented with post-menopausal blood loss. In 17 patients (73.9%) the intra-epithelial lesion was present in an endometrial polyp. All patients underwent hysterectomy, of whom 12 patients (52.2%) were surgically staged. None of the staged patients showed extra-uterine disease. Two patients received adjuvant brachytherapy. There were no recurrences of disease (median follow-up duration of 35.6 months (range 1.0-108.6) and no disease-related deaths in this cohort. In patients with serous endometrial intra-epithelial carcinoma, median progression-free survival reached nearly 3 years and no recurrences have been reported. Our results do not endorse World Health Organization 2014 advice to treat serous endometrial intra-epithelial carcinoma as high-grade, high-risk endometrial carcinoma. Full surgical staging might possibly lead to overtreatment.

Linked Investigators

Ciska Slaager

Heleen van Beekhuizen