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Clinical Trials/NCT04569773
NCT04569773Active, not recruitingNot Applicable

Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial

Memorial Sloan Kettering Cancer Center16 sites in 1 country43 target enrollmentStarted: September 23, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
43
Locations
16
Primary Endpoint
Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer

Time Frame: Up to 12 months post-operatively

Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer to identify influencing factors-in particular, cancer-related psychological distress and reproductive concerns-and any potential decisional regrets following surgical intervention.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (16)

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