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Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

RecruitingNAAges 18 Years - 90 YearsFemaleAnthony Costales, MD
NCT04586959 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Surgery with UM
  • Surgery without UM
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Where

5 sites
Cleveland Clinic
Cleveland, United States
Baylor College of Medicine- McNair Campus
Houston, United States
Baylor College of Medicine
Houston, United States
Ben Taub General Hospital
Houston, United States
Harris Health System - Smith Clinic
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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