Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Description

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

ENDOMETRIAL CANCER

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Study Overview

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Study Details

Study overview

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.

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Condition
ENDOMETRIAL CANCER
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Houston

Baylor College of Medicine- McNair Campus, Houston, Texas, United States, 77030

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Houston

Ben Taub General Hospital, Houston, Texas, United States, 77030

Houston

Harris Health System - Smith Clinic, Houston, Texas, United States, 77054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 1. Planned laparotomic hysterectomy
  • 2. On progesterone therapy to treat their endometrial cancer
  • 3. Any prior pelvic irradiation

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Anthony Costales, MD,

Anthony Costales, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

2025-10