NCT04362046 Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
| NCT ID | NCT04362046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vancouver Coastal Health Research Institute |
| Condition | Endometrial Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-11-15 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2020-11-15 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study protocol evaluates the use of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. Patients in this study wish to preserve fertility.
Eligibility Criteria
All candidates for this protocol must have an adequate trial of anti-hormone therapy prior to hysteroscopic resection. In cases of EC, the minimum trial is 6 months of high-dose progestin. In cases of AH, being that this is a benign condition (pre-malignant), patients may not require a full 6 months of anti-hormone therapy. All patients must have a pre-HR hysteroscopic evaluation to confirm that they are suitable candidates for this study. Patients being considered for the experimental intervention (hysteroscopic resection) will be reviewed and discussed by the study committee in order to ensure that the following criterion are met in order to proceed with the surgical resection: Inclusion criteria: * Age less than 40 years * Pathologist confirmed biopsy evidence of one of the following: 1. Grade I endometrial endometrioid adrenocarcinoma (EC) with less than 1/3 of the endometrial surface involved. 2. Atypical endometrial hyperplasia (AH) * MRI demonstrating less than 1/3 myometrial invasion if the patient has EC * Absence of significant surgical co-morbidities e.g. pulmonary hypertension, significant cardiac valvular disease, or contraindication to surgery. * Desire to preserve fertility * Reasonable chance to conceive based on consultation with an infertility specialist * Adequate dose and duration of progesterone therapy prior to enrolment: * Adequate dose: 1. Medroxyprogesterone acetate (Provera; 200mg/day) 2. Megestrol acetate (Megace; 160mg/day) * Adequate duration: 6 months * Failure of progestin therapy defined as: 1. Unsuccessful eradication of hyperplasia or cancer in the uterus 2. Intolerance to the side effects * Signed informed consent Exclusion criteria: * Age 40 years and over * Grade 2 or 3 endometrioid endometrial adenocarcinoma or non-endometrioid pathology * Greater than 1/3 involvement of the endometrial surface in patients with Grade I EC * Women who are not able to provide informed consent * Women without pathologic confirmation of low-grade endometrioid carcinoma or AH * Myometrial invasion on MRI greater than 1/3 total myometrial thickness. * MRI evidence of ovarian or adnexal involvement * The diagnosis of another cancer or medical condition that would interfere with the assessment of the hysteroscopic surgery success rates. * Significant underlying fertility impairment that would significantly interfere with the success rate of HR
Contact & Investigator
Mark Carey, MD
PRINCIPAL INVESTIGATOR
Vancouver Coastal Health
Frequently Asked Questions
Who can join the NCT04362046 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 39 Years, studying Endometrial Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04362046 currently recruiting?
Yes, NCT04362046 is actively recruiting participants. Contact the research team at neeraj.mehra@ubc.ca for enrollment information.
Where is the NCT04362046 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT04362046 clinical trial?
NCT04362046 is sponsored by Vancouver Coastal Health Research Institute. The principal investigator is Mark Carey, MD at Vancouver Coastal Health. The trial plans to enroll 30 participants.