Actively Recruiting
Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Led by Anthony Costales, MD · Updated on 2025-10-15
278
Participants Needed
5
Research Sites
332 weeks
Total Duration
On this page
Sponsors
A
Anthony Costales, MD
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
- Pre-operative imaging not showing signs of disease outside the uterus, if imaging was done
- CA 125 blood test is optional, but if done must be within normal lab values
- ECOG performance status between 0 and 2
- Signed informed consent and ability to follow up
- Considered suitable for minimally invasive surgery by the treating doctor
You will not qualify if you...
- Planned surgery involving laparotomy (large incision) hysterectomy
- Currently on progesterone therapy to treat endometrial cancer
- Previous radiation therapy to the pelvic area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Suspended
2
Baylor College of Medicine- McNair Campus
Houston, Texas, United States, 77030
Actively Recruiting
3
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
4
Ben Taub General Hospital
Houston, Texas, United States, 77030
Actively Recruiting
5
Harris Health System - Smith Clinic
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
A
Anthony Costales, MD
CONTACT
R
Roberto Vargas, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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