Brief Title
Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Official Title
Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial
Brief Summary
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.
Study Type
Observational
Primary Outcome
Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer
Condition
Endometrial Cancer
Intervention
Impact of Event Scale-Revised
Study Arms / Comparison Groups
Participants undergoing surgery for clinical
Description: Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
100
Start Date
September 23, 2020
Completion Date
September 23, 2024
Primary Completion Date
September 23, 2024
Eligibility 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
Gender
Female
Ages
18 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Jennifer Mueller, MD, 212-639-8229, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04569773
Organization ID
20-429
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Jennifer Mueller, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
March 2023