Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Recruiting now · Not applicable
Conditions studied: ENDOMETRIAL CANCER
In brief
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.
Key facts
- Study ID
- NCT04586959
- Run by
- Anthony Costales, MD
- People needed
- 278
- Starts
- 2021-05-21
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2025-10-15
Who can join
Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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).
- 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.
You may not qualify if…
- A subject must not have any of the following criteria:
- Planned laparotomic hysterectomy
- On progesterone therapy to treat their endometrial cancer
- Any prior pelvic irradiation
Where it is running
- Baylor College of Medicine- McNair Campus — Houston, Texas, United States (enrolling)
- Baylor College of Medicine — Houston, Texas, United States (enrolling)
- Ben Taub General Hospital — Houston, Texas, United States (enrolling)
- Harris Health System - Smith Clinic — Houston, Texas, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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