Investigating the impact of an intrauterine manipulator on peritoneal cytology in early stage endometrial cancer
Official title: Use of an Intrauterine Manipulator and Its Correlation with Positive Peritoneal Cytology in Early Stage Endometrial Cancers
Run by WellSpan Health · NCT04570553 · Data updated 2026-11-12
This study is testing if using a special tool during surgery for early stage endometrial cancer affects the chances of finding cancer cells in the abdominal fluid.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 350 (estimated) |
| Sponsor | WellSpan Health Academic / other |
| Locations | 1 site (York, Pennsylvania) |
| Status | Recruiting |
| Started | October 15, 2020 |
| Main results expected | April 30, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | March 28, 2025 |
| Trial ID | NCT04570553 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women aged 18 or older with biopsy-confirmed early stage endometrial cancer who are planning to undergo standard surgical management.
✕Probably not a fit
Patients with disseminated intraperitoneal disease or those opting for fertility-sparing or non-operative management may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to determine whether the use of a Vcare® intrauterine manipulator during surgical management affects the incidence of positive peritoneal cytology in patients with early stage endometrial cancer. Endometrial cancer is a prevalent gynecologic cancer, and while most patients are diagnosed early, some experience recurrence. The study will involve patients aged 18 and older who have been diagnosed with endometrial cancer and are scheduled for standard surgical treatment. By analyzing the correlation between the manipulator's use and peritoneal cytology outcomes, the study seeks to clarify the role of positive peritoneal cytology in recurrence risk.
Why it matters
Potential benefit: If successful, this study could improve the understanding of recurrence risks in early stage endometrial cancer, potentially leading to better management strategies.
How similar studies have gone: Previous studies have shown mixed results regarding the significance of positive peritoneal cytology in endometrial cancer, making this investigation both relevant and necessary.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects age 18 or older able to give informed consent * Biopsy diagnosed endometrial cancer (including endometrioid, serous, mucinous and clear cell histologies) * Planned standard of care surgical management of early stage endometrial cancer * No clinical evidence of disseminated intraperitoneal disease Exclusion Criteria: * Final pathology does not reflect diagnosis of endometrial cancer (including endometrioid, serous, mucinous, and clear cell histology) * Evidence of disseminated intraperitoneal disease * Subject is not a surgical candidate * Subject elects for fertility sparing or non-operative management * Subject is unable to provide informed consent
Where it's running
-
Wellspan Health
York, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Eav Lim, DO — WellSpan Health
- Study coordinator: Graham Brown, DO
- Email: gbrown5@wellspan.org
- Phone: 717-851-6120
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.