Choosing between ovarian preservation or removal for endometrial cancer surgery
Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial
Memorial Sloan Kettering Cancer Center · NCT04569773
This study looks at how women with endometrial cancer decide whether to keep or remove their ovaries during surgery, focusing on their feelings and concerns about cancer and future regrets.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Hartford, Connecticut and 7 other locations) |
| Trial ID | NCT04569773 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the factors influencing women's decision-making regarding ovarian preservation or removal before surgery for endometrial cancer. It focuses on the emotional distress related to cancer and reproductive concerns, as well as the potential for regret after surgery. Participants will complete various scales to assess their experiences and feelings related to these decisions. The study is conducted at Memorial Sloan Kettering Cancer Center and its affiliated locations.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women aged 18 to 50 with a diagnosis of endometrioid endometrial cancer who are scheduled for surgical intervention.
Not a fit: Patients with known Lynch syndrome, prior bilateral oophorectomy, or those at increased risk of ovarian cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help women make more informed decisions about their surgical options for endometrial cancer, potentially improving their emotional well-being and satisfaction with their choices.
How similar studies have performed: Other studies have explored decision-making in cancer treatment, but this specific focus on ovarian preservation versus removal in endometrial cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Hartford, Connecticut and 7 other locations
- Hartford Healthcare (Data Collection) — Hartford, Connecticut, United States (RECRUITING)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Bergen (All protocol activities) — Montvale, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center @ Suffolk (All protocol activities) — Commack, New York, United States (RECRUITING)
- Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center (All Study Activities) — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Jennifer Mueller, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jennifer Mueller, MD
- Email: muellerj@mskcc.org
- Phone: 212-639-8229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometrial Cancer, Ovarian Preservation, Ovarian Removal, Endometrial Malignancies, GYN POEM Trial, 20-429, Memorial Sloan Kettering Cancer Center