Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Behavioral: Impact of Event Scale-Revised; Behavioral: Reproductive Concerns Scale; Behavioral: Decision Regret Scale

• Registration Number: NCT04569773
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-23
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-09-23
• Study Completion: 2025-09-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants undergoing surgery for clinical	Reproductive Concerns Scale	Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer
Participants undergoing surgery for clinical	Impact of Event Scale-Revised	Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer
Participants undergoing surgery for clinical	Decision Regret Scale	Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer

Primary Outcome Measures

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

Trial Locations

Locations (8)

Hartford Healthcare (Data Collection); 🇺🇸 Hartford, Connecticut, United States

Memorial Sloan Kettering Bergen (All protocol activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (All protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk (All protocol activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (All protocol activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Study Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities); 🇺🇸 Rockville Centre, New York, United States