NCT04586959Recruiting
Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 15 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 278 (estimated)
- First submitted
- 7 Oct 2020
- Start date
- 21 May 2021
- Primary completion date
- Jul 2027
- Lead sponsor
- Anthony Costales, MD
- Diseases
- Endometrial cancer
- NCT number
- NCT04586959
What you commit to
- Study type: Interventional
- Planned participants: 278
- From 21 May 2021 to the primary completion date, Jul 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior pelvic irradiation
Other illness
- On progesterone therapy to treat their endometrial cancer
Other
- A subject must not have any of the following criteria:
- Planned laparotomic hysterectomy
Who the study is looking for
- A subject will be considered eligible for inclusion in this study if all the following criteria are met:
- Patient must be greater than or equal to 18 years old.
- Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
- Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.
- 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.
Age in the registry: 18 years to 90 years · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Suspended |
| Ben Taub General Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Harris Health System - Smith Clinic Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Baylor College of Medicine- McNair Campus Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.