Endometrial CancerNCT04569773
Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
An observational study of Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Impact of Event Scale-Revised, Reproductive Concerns Scale and Decision Regret Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 43 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Sep 2020to 23 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- Normal ovaries on preoperative imaging
- Able to provide informed consent
- English-speaking
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk (All protocol activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Hartford Healthcare (Data Collection)
Hartford, Connecticut, 06102
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Study Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
About this study
Official title: Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial
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.
- Conditions
- Endometrial Cancer
- Being tested
- Impact of Event Scale-Revised, Reproductive Concerns Scale, Decision Regret Scale
- Keywords
- Endometrial Cancer, Ovarian Preservation, Ovarian Removal, Endometrial Malignancies, GYN POEM Trial, 20-429, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of Event Scale-RevisedBehavioural
Also called IES-R
The IES-R is a validated 22-item self-report scale measuring psychological stress reactions after a major life or traumatic event.1-3Items are rated with reference to the past 7 days on a 5-point scale, ranging from 0 to 4. Three subscale scores are calculated by taking the mean of the item responses: Intrustion (8 items), Avoidance (8 items), and Hyperarousal (6 items). The total score is similarly computed by taking the mean of all 22 items. All scores range from 0 to 4, with higher scores indicating higher event-related distress. Internal consistency estimates(Cronbach's alpha) for all scores range between 0.79 to 0.92.
Reproductive Concerns ScaleBehavioural
Also called RCS
The RCS is a 14-item, 5-point Likert-type self-report measure that assesses concern among cancer survivors whose reproductive ability may have been impaired or lost due to disease and/or treatment. Answers are rated on a 5-point scale (0 to 4), and a single total score is produced by summing responses to all 14 items (range, 0-56 points). A higher score represents more reproductive concerns, and a lower score represents fewer reproductive concerns. In the RCS validation study, internal consistency reliability was 0.91 among long-term female cancer survivors and 0.81 among control women.
Decision Regret ScaleBehavioural
Also called DRS
The DRS is a 5-item, 5-point Likert-type self-report measure that assesses distress or remorse after a health-care decision.5 Items are rated on a scale from 1 ("strongly agree") to 5 ("strongly disagree"). Two of the statements (items 2 and 4) are phrased in the negative direction.
A single, total score is produced by first reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items. This mean is then rescaled to range from 0 to 100 by subtracting 1, then multiplying by 25. A score of 0 indicates no regret, whereas a score of 100 indicates high regret. Internal consistency reliability coefficients for the DRS range from 0.81 to 0.92.
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing surgery for clinical | Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer Receives: Behavioral: Impact of Event Scale-Revised; Behavioral: Reproductive Concerns Scale; Behavioral: Decision Regret Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer
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.
Measured: Up to 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start23 Sep 2020
- Primary completion23 Sep 2027 (estimated)
- Study completion23 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Mueller, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569773
- Sponsor's protocol ID
- 20-429
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial
- ClinicalTrials.gov ID
- NCT04569773
- Acronym / sponsor ID
- 20-429
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Ovarian Preservation, Ovarian Removal, Endometrial Malignancies, GYN POEM Trial, 20-429, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 23 Sep 2027 (estimated)
- Study completion
- 23 Sep 2027 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing surgery for clinical | – | Behavioral: Impact of Event Scale-Revised, Behavioral: Reproductive Concerns Scale, Behavioral: Decision Regret ScaleParticipants will be undergoing surgery for clinical stage I endometrioid endometrial cancer |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- Women aged ≥ 18 and ≤ 50 years
- Premenopausal
- Endometrioid histological diagnosis
- Scheduled for surgical intervention at MSKCC
- FIGO grade 1-2, clinical stage I
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of Event Scale-RevisedAlso: IES-RThe IES-R is a validated 22-item self-report scale measuring psychological stress reactions after a major life or traumatic event.1-3Items are rated with reference to the past 7 days on a 5-point scale, ranging from 0 to 4. Three subscale scores are calculated by taking the mean of the item responses: Intrustion (8 items), Avoidance (8 items), and Hyperarousal (6 items). The total score is similarly computed by taking the mean of all 22 items. All scores range from 0 to 4, with higher scores indicating higher event-related distress. Internal consistency estimates(Cronbach's alpha) for all scores range between 0.79 to 0.92. | Behavioural | Participants undergoing surgery for clinical |
| Reproductive Concerns ScaleAlso: RCSThe RCS is a 14-item, 5-point Likert-type self-report measure that assesses concern among cancer survivors whose reproductive ability may have been impaired or lost due to disease and/or treatment. Answers are rated on a 5-point scale (0 to 4), and a single total score is produced by summing responses to all 14 items (range, 0-56 points). A higher score represents more reproductive concerns, and a lower score represents fewer reproductive concerns. In the RCS validation study, internal consistency reliability was 0.91 among long-term female cancer survivors and 0.81 among control women. | Behavioural | Participants undergoing surgery for clinical |
| Decision Regret ScaleAlso: DRSThe DRS is a 5-item, 5-point Likert-type self-report measure that assesses distress or remorse after a health-care decision.5 Items are rated on a scale from 1 ("strongly agree") to 5 ("strongly disagree"). Two of the statements (items 2 and 4) are phrased in the negative direction. A single, total score is produced by first reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items. This mean is then rescaled to range from 0 to 100 by subtracting 1, then multiplying by 25. A score of 0 indicates no regret, whereas a score of 100 indicates high regret. Internal consistency reliability coefficients for the DRS range from 0.81 to 0.92. | Behavioural | Participants undergoing surgery for clinical |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Mueller, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.