RECRUITING

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Quick Facts

Study Start:2021-05-21
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04586959

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient must be greater than or equal to 18 years old.
  2. 2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
  3. 3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.
  4. 4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1).
  5. 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. 1. Planned laparotomic hysterectomy
  2. 2. On progesterone therapy to treat their endometrial cancer
  3. 3. Any prior pelvic irradiation

Contacts and Locations

Study Contact

Anthony Costales, MD
CONTACT
713-798-3495
costales@bcm.edu
Roberto Vargas, MD
CONTACT
216-444-3414
vargasr@ccf.org

Principal Investigator

Anthony Costales, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States
Baylor College of Medicine- McNair Campus
Houston, Texas, 77030
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Ben Taub General Hospital
Houston, Texas, 77030
United States
Harris Health System - Smith Clinic
Houston, Texas, 77054
United States

Collaborators and Investigators

Sponsor: Anthony Costales, MD

  • Anthony Costales, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-21
Study Completion Date2025-10

Study Record Updates

Study Start Date2021-05-21
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • endometrial
  • cancer
  • uterine
  • manipulator

Additional Relevant MeSH Terms

  • ENDOMETRIAL CANCER