Clinical trial NCT04569773: Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Official title: Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer
Ovarian Preservation
Ovarian Removal
Endometrial Malignancies
GYN POEM Trial
20-429
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Gynecology Service, Department of Surgery, at MSK. All women undergoing surgery for endometrial cancer without clear preoperative suspicion for advanced-stage disease will be screened for participation in this study. No selectivity will be exercised by the investigators to minimize bias. The specific type of surgery for each patient, as well as its timing, will be determined by the treating gynecological surgeon.

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.


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

Primary outcomes:
measure: Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer
timeFrame: Up to 12 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare (Data Collection)
state: Connecticut
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk (All protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All protocol activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Study Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References: