Evaluating uterine manipulation during minimally invasive surgery for early stage endometrial cancer
Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
NA · Baylor College of Medicine · NCT04586959
This study is testing if using a tool to help move the uterus during surgery for early stage endometrial cancer affects the spread of cancer cells in the surgical fluid.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 278 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Baylor College of Medicine (other) |
| Locations | 5 sites (Cleveland, Ohio and 4 other locations) |
| Trial ID | NCT04586959 on ClinicalTrials.gov |
What this trial studies
This study investigates whether the use of a uterine manipulator during minimally invasive surgery for early stage endometrial cancer affects the presence of cancer cells in the surgical fluid. Patients will be randomly assigned to two groups: one receiving surgery with a uterine manipulator and the other without. The aim is to determine if the manipulator increases the risk of cancer cell spread during the procedure. This research addresses a significant gap in understanding the potential risks associated with this common surgical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with suspected early stage endometrial cancer and no signs of extra-uterine disease.
Not a fit: Patients who are planned for laparotomic hysterectomy or those on progesterone therapy for endometrial cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical practices that minimize the risk of cancer spread during surgery.
How similar studies have performed: While there is limited research directly addressing this issue, the study aims to fill a gap in existing knowledge regarding uterine manipulators in surgical procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A subject will be considered eligible for inclusion in this study if all the following criteria are met: 1. Patient must be greater than or equal to 18 years old. 2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous) 3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively. 4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1). 6\. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure. Exclusion Criteria: A subject must not have any of the following criteria: 1. Planned laparotomic hysterectomy 2. On progesterone therapy to treat their endometrial cancer 3. Any prior pelvic irradiation
Where this trial is running
Cleveland, Ohio and 4 other locations
- Cleveland Clinic — Cleveland, Ohio, United States (SUSPENDED)
- Baylor College of Medicine- McNair Campus — Houston, Texas, United States (RECRUITING)
- Baylor College of Medicine — Houston, Texas, United States (RECRUITING)
- Ben Taub General Hospital — Houston, Texas, United States (RECRUITING)
- Harris Health System - Smith Clinic — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Anthony Costales, MD — Baylor College of Medicine
- Study coordinator: Anthony Costales, MD
- Email: costales@bcm.edu
- Phone: 713-798-3495
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.
Conditions: ENDOMETRIAL CANCER, endometrial, cancer, uterine, manipulator