Evaluating uterine manipulation during minimally invasive surgery for early stage endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether the use of a uterine manipulator during minimally invasive surgery for early stage endometrial cancer affects the presence of cancer cells in the surgical fluid. Patients will be randomly assigned to two groups: one receiving surgery with a uterine manipulator and the other without. The aim is to determine if the manipulator increases the risk of cancer cell spread during the procedure. This research addresses a significant gap in understanding the potential risks associated with this common surgical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Baylor College of Medicine- McNair Campus
  Houston, Texas, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting
• Ben Taub General Hospital
  Houston, Texas, United States Recruiting
• Harris Health System - Smith Clinic
  Houston, Texas, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Suspended

Study contacts

• Principal investigator: Anthony Costales, MD — Baylor College of Medicine
• Study coordinator: Anthony Costales, MD
• Email: costales@bcm.edu
• Phone: 713-798-3495

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized navigation to support rural and Black women with endometrial cancer

  This pilot tests a tailored patient-navigation program to help rural and Black patients with endometrial cancer access care and services.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT07927244

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

• One-Finger Technique to identify the left upper ureter during para-aortic lymphadenectomy

  This study tests a new surgical method to help surgeons find the left upper ureter during open para-aortic lymphadenectomy in women with gynecologic cancers.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07895212

• Liquid biopsy screening for early endometrial cancer in regional China

  A non-invasive blood test using cell-free DNA is being tested to see if it can detect early endometrial cancer and tell apart benign from malignant uterine lesions.

  Recruiting Guizhou Provincial People's Hospital · Guiyang, Guizhou · NCT07892755

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.