Actively Recruiting
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Led by Vancouver Coastal Health Research Institute · Updated on 2021-10-20
30
Participants Needed
1
Research Sites
397 weeks
Total Duration
On this page
Sponsors
V
Vancouver Coastal Health Research Institute
Lead Sponsor
U
University of British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than 40 years
- Confirmed biopsy evidence of grade I endometrial endometrioid adenocarcinoma involving less than one-third of the endometrial surface or atypical endometrial hyperplasia
- MRI showing less than one-third myometrial invasion if diagnosed with endometrial cancer
- No significant surgical co-morbidities such as pulmonary hypertension or significant cardiac valvular disease
- Desire to preserve fertility
- Reasonable chance to conceive as assessed by an infertility specialist
- Adequate dose of progesterone therapy (Medroxyprogesterone acetate 200 mg/day or Megestrol acetate 160 mg/day)
- Adequate duration of progesterone therapy for 6 months
- Failure of progestin therapy defined by unsuccessful eradication of hyperplasia or cancer or intolerance to side effects
- Signed informed consent
You will not qualify if you...
- Age 40 years and older
- Grade 2 or 3 endometrioid endometrial adenocarcinoma or non-endometrioid pathology
- More than one-third involvement of the endometrial surface in grade I endometrial cancer
- Inability to provide informed consent
- Lack of pathologic confirmation of low-grade endometrioid carcinoma or atypical hyperplasia
- Myometrial invasion greater than one-third on MRI
- MRI evidence of ovarian or adnexal involvement
- Diagnosis of another cancer or medical condition interfering with assessment of surgery success
- Significant fertility impairment likely to interfere with success of hysteroscopic resection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
Research Team
N
Neeraj Mehra, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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