RecruitingNot ApplicableNCT04362046

Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia

Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer


Sponsor

Vancouver Coastal Health Research Institute

Enrollment

30 participants

Start Date

Nov 15, 2020

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 19 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a surgical technique — hysteroscopic resection (a minimally invasive procedure through the cervix) — as a fertility-sparing option for women with early uterine (endometrial) cancer or abnormal uterine lining (complex hyperplasia) who wish to preserve their ability to have children. Standard treatment involves removing the uterus, but this approach explores whether surgery combined with hormone therapy can safely manage early disease. **You may be eligible if:** - You have early-stage endometrial cancer or complex uterine hyperplasia (abnormal but pre-cancerous uterine lining) and wish to preserve fertility - You have already completed an adequate course of hormone therapy (typically at least 6 months for cancer cases) - A preliminary evaluation has confirmed you are a suitable candidate for the surgical procedure - The study team has reviewed and approved your case **You may NOT be eligible if:** - Your cancer is at an advanced stage or has features that make fertility-sparing treatment unsafe - You have not completed the required hormone therapy trial - You are not deemed a suitable candidate upon pre-surgical evaluation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHysteroscopic uterine resection

Hysteroscopic 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.


Locations(1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

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NCT04362046


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