NCT04362046Recruiting
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 20 Oct 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Apr 2020
- Start date
- 15 Nov 2020
- Primary completion date
- Jul 2028
- Lead sponsor
- Vancouver Coastal Health Research Institute
- Diseases
- Endometrial cancer
- NCT number
- NCT04362046
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Nov 2020 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Age 40 years and over
Other
- 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
Who the study is looking for
- Age less than 40 years
- Pathologist confirmed biopsy evidence of one of the following:
- Grade I endometrial endometrioid adrenocarcinoma (EC) with less than 1/3 of the endometrial surface involved.
- 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:
- Medroxyprogesterone acetate (Provera; 200mg/day)
- Megestrol acetate (Megace; 160mg/day)
- Adequate duration: 6 months
- Failure of progestin therapy defined as:
- Unsuccessful eradication of hyperplasia or cancer in the uterus
- Intolerance to the side effects
- Signed informed consent
Criteria the registry did not label
- 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:
Age in the registry: 19 years to 39 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.