Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-39
SponsorVancouver Coastal Health Research Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age less than 40 years
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Hysteroscopic uterine resection
Procedure/SurgeryHysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy. HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Hysteroscopic uterine resectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Conception rate of women attempting pregnancy
live births / women attempting pregnancy
Time frame
3 years post-resection2
Overall conception rate
live births / all women participating in study, including those who failed hysteroscopic resection and have a hysterectomy
Time frame
3 years post-resection3
Local disease control rate (short-term failure of hysteroscopic resection)
Patients with persisting atypical hyperplasia or Grade I endometrial cancer / patients treated with hysteroscopic resection
Time frame
3 months post-resection4
Distant disease control rate (long-term failure of hysteroscopic resection)
patients developing distant recurrence / patients treated with hysteroscopic resection
Time frame
3 years post-resectionSecondary outcomes
1
Complications/side-effects
The investigators will tabulate complications/side-effects of the procedure such as the rate of uterine perforation, uterine adhesion, procedure infection, and others.
Time frame
3 years post-resectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vancouver Coastal Health Research Institute
Lead sponsor
University of British Columbia
Collaborator
Source ClinicalTrials.gov