Investigating the impact of an intrauterine manipulator on peritoneal cytology in early stage endometrial cancer
Use of an Intrauterine Manipulator and Its Correlation with Positive Peritoneal Cytology in Early Stage Endometrial Cancers
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | WellSpan Health Academic / other |
| Locations | 1 site (York, Pennsylvania) |
| Trial ID | NCT04570553 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with disseminated intraperitoneal disease or those opting for fertility-sparing or non-operative management may not benefit from this study.
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 performed: Previous studies have shown mixed results regarding the significance of positive peritoneal cytology in endometrial cancer, making this investigation both relevant and necessary.
Eligibility criteria
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 this trial is running
York, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.