Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer (MAN-U)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586959
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Anthony Costales, MD, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
ENDOMETRIAL CANCER Device: Surgery with UM Device: Surgery without UM Not Applicable

Detailed Description:

In most cases, patients who have early stage endometrial cancer undergo a surgery to remove the uterus, cervix, tubes, ovaries, and occasionally lymph nodes. This is usually done through a minimally invasive (not a large incision) surgery. To accomplish this, the uterus needs to be manipulated (moved around) to help the surgeon complete your surgery. This is usually done with a device called a uterine manipulator and the majority of surgeons use this device in any patient undergoing a minimally invasive hysterectomy (removal of the uterus and cervix).

Even though the majority of surgeons use a manipulator, there are some surgeons who believe there is a possibility that cancer cells inside the uterus can be spilled into the abdomen through the fallopian tubes. This may cause a higher risk of spreading the cancer and or of the cancer coming back.

Currently, there are very limited research studies directly looking at whether the uterine manipulator may cause these cells to appear in the abdomen.

The purpose of this study is to see 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.

A computer program will randomly assign the subjects to one of two groups. One group will have minimally invasive surgery with the use of a uterine manipulator and the other group will have minimally invasive surgery without the use of a uterine manipulator.

Researchers will use the information from this study to decide how best to take care of patients undergoing minimally invasive surgery for uterine cancer.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective multi-center non-inferiority randomized study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Actual Study Start Date : May 21, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : October 2025

Arm Intervention/treatment
Experimental: Surgery With UM (Arm MAN UA)
Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)
Device: Surgery with UM
The experimental group will have MIS with the placement of a uterine manipulator

Active Comparator: Surgery Without UM (Arm Control)
Subjects that undergo a MIS approach without a uterine manipulator (control arm)
Device: Surgery without UM
The control group will have MIS without the placement of a uterine manipulator




Primary Outcome Measures :
  1. Positive peritoneal cytology (PC) [ Time Frame: Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group ]
    Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.


Secondary Outcome Measures :
  1. Post-operative positive PC [ Time Frame: Immediately after closure of the vaginal cuff ]
    Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.

  2. Lymphovascular space invasion (LVSI) [ Time Frame: During surgery ]
    LVSI is defined as the presence of tumor cells within a definite endothelial-lined space (lymphatics or blood vessels) at the advancing edge of the tumor as it invades the myometrium, within an endometrial polyp, or within the endometrial stroma.

  3. Percentage of myometrial invasion (MI) [ Time Frame: During surgery ]
    Defined as the % of invasion into the myometrium from the endomyometrial junction

  4. Extent of lymph node metastases [ Time Frame: During surgery ]
    Defined as presence of isolated tumor cells (ITC - <0.2 mm), or micrometastasis (mm - 0.2 - 2 mm), or macrometastasis (MM - > 2 mm), whichever is greater.

  5. Operative time [ Time Frame: 1 day ]
    Defined as time from start of operation to closure of skin in minutes as documented in the electronic medical record

  6. Surgical morbidity [ Time Frame: Intra-operative and up to 30 days post-surgery ]
    Surgical morbidity (CTCAE v5.0) grade 3 and higher, or any grade of the following adverse events: colonic fistula, colonic perforation, enterovesical fistula, gastrointestinal fistula, ileus, intra-abdominal hemorrhage, rectal fistula, rectal perforation, small intestinal perforation, abdominal infection, pelvic infection, vaginal infection, intra-operative arterial injury, venous injury, intra-operative gastrointestinal injury, intra-operative hemorrhage, intra-operative neurological injury, intra-operative urinary injury, and post-operative hemorrhage.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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 at the time of diagnosis or used as therapy to treat their endometrial cancer
  3. Any prior pelvic irradiation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586959


Contacts
Layout table for location contacts
Contact: Anthony Costales, MD 713-798-3495 costales@bcm.edu
Contact: Roberto Vargas, MD 216-444-3414 vargasr@ccf.org

Locations
Layout table for location information
United States, Texas
Baylor College of Medicine- McNair Campus Not yet recruiting
Houston, Texas, United States, 77030
Contact: Anthony Costales, MD    713-798-3495    costales@bcm.edu   
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Anthony Costales, MD    713-798-3495    costales@bcm.edu   
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Anthony Costales, MD    713-798-3495    costales@bcm.edu   
Harris Health System - Smith Clinic Recruiting
Houston, Texas, United States, 77054
Contact: Anthony Costales, MD    713-798-3495    costales@bcm.edu   
Sponsors and Collaborators
Anthony Costales, MD
Investigators
Layout table for investigator information
Principal Investigator: Anthony Costales, MD Baylor College of Medicine
Layout table for additonal information
Responsible Party: Anthony Costales, MD, Assistant Professor Obstetrics & Gynecology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04586959    
Other Study ID Numbers: H-46373
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Anthony Costales, MD, Baylor College of Medicine:
endometrial
cancer
uterine
manipulator
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases