ACTIVE_NOT_RECRUITING

Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Conditions

Endometrial Cancer Ovarian Preservation Ovarian Removal Endometrial Malignancies GYN POEM Trial 20-429 Memorial Sloan Kettering Cancer Center

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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

The purpose of this study is to learn more about the factors that influence decision-making before surgery (distress about cancer and/or reproductive concerns) and the possibility of regret after surgery.

Official Title

Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial

Quick Facts

Study Start:2020-09-23

Study Completion:2026-09-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04569773

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 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Women aged ≥ 18 and ≤ 50 years * Premenopausal * Endometrioid histological diagnosis * Scheduled for surgical intervention at MSKCC * FIGO grade 1-2, clinical stage I * Disease confined to uterus, no clear evidence of deep (≥50%) myoinvasion on imaging (MRI preferred, ultrasound optional) * Normal ovaries on preoperative imaging * Able to provide informed consent * English-speaking	* Known Lynch syndrome * Prior bilateral oophorectomy * Personal history of hormone receptor-positive breast carcinoma * Increased risk of ovarian cancer identified on the basis of family or personal history * Women currently on hormonal contraception, letrozole, or tamoxifen may not opt-in to AMH * Women who recently underwent ovarian stimulation within the past 3 months may not opt-in to AMH * Women who have pituitary dysfunction (or any pituitary disorders) may not opt-in to AMH * Women who completed chemotherapy within \<12 months may not opt-in to AMH

Inclusion Criteria

Exclusion Criteria

* Women aged ≥ 18 and ≤ 50 years
* Premenopausal
* Endometrioid histological diagnosis
* Scheduled for surgical intervention at MSKCC
* FIGO grade 1-2, clinical stage I
* Disease confined to uterus, no clear evidence of deep (≥50%) myoinvasion on imaging (MRI preferred, ultrasound optional)
* Normal ovaries on preoperative imaging
* Able to provide informed consent
* English-speaking

* Known Lynch syndrome
* Prior bilateral oophorectomy
* Personal history of hormone receptor-positive breast carcinoma
* Increased risk of ovarian cancer identified on the basis of family or personal history
* Women currently on hormonal contraception, letrozole, or tamoxifen may not opt-in to AMH
* Women who recently underwent ovarian stimulation within the past 3 months may not opt-in to AMH
* Women who have pituitary dysfunction (or any pituitary disorders) may not opt-in to AMH
* Women who completed chemotherapy within \<12 months may not opt-in to AMH

Contacts and Locations

Principal Investigator

Jennifer Mueller, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Hartford Healthcare (Data Collection)

Hartford, Connecticut, 06102

United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Cancer Center @ Suffolk (All protocol activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Study Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Jennifer Mueller, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Date2020-09-23

Study Completion Date2026-09-23

Study Record Updates

Study Start Date2020-09-23

Study Completion Date2026-09-23

Terms related to this study

Keywords Provided by Researchers

Endometrial Cancer
Ovarian Preservation
Ovarian Removal
Endometrial Malignancies
GYN POEM Trial
20-429
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Endometrial Cancer