NCT04586959

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
May 2021Oct 2027

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

6.1 years

First QC Date

October 7, 2020

Last Update Submit

October 13, 2025

Conditions

ENDOMETRIAL CANCER

Keywords

endometrialcanceruterinemanipulator

Outcome Measures

Primary Outcomes (1)

  • Positive peritoneal cytology (PC)

    Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.

    Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group

Secondary Outcomes (6)

  • Post-operative positive PC

    Immediately after closure of the vaginal cuff

  • Lymphovascular space invasion (LVSI)

    During surgery

  • Percentage of myometrial invasion (MI)

    During surgery

  • Extent of lymph node metastases

    During surgery

  • Operative time

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Surgery With UM (Arm MAN UA)

EXPERIMENTAL

Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)

Device: Surgery with UM

Surgery Without UM (Arm Control)

ACTIVE COMPARATOR

Subjects that undergo a MIS approach without a uterine manipulator (control arm)

Device: Surgery without UM

Interventions

Surgery with UMDEVICE

The experimental group will have MIS with the placement of a uterine manipulator

Surgery With UM (Arm MAN UA)
Surgery without UMDEVICE

The control group will have MIS without the placement of a uterine manipulator

Surgery Without UM (Arm Control)

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be greater than or equal to 18 years old.
  • Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
  • Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.
  • CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1).
  • \. 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.

You may not qualify if:

  • A subject must not have any of the following criteria:
  • Planned laparotomic hysterectomy
  • On progesterone therapy to treat their endometrial cancer
  • Any prior pelvic irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

SUSPENDED

Baylor College of Medicine- McNair Campus

Houston, Texas, 77030, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Ben Taub General Hospital

Houston, Texas, 77030, United States

RECRUITING

Harris Health System - Smith Clinic

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsNeoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Anthony Costales, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Costales, MD

CONTACT

713-798-3495costales@bcm.edu

Roberto Vargas, MD

CONTACT

216-444-3414vargasr@ccf.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective multi-center non-inferiority randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor Obstetrics & Gynecology

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

May 21, 2021

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(5)