Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia

Not Applicable

Recruiting

• Conditions: Endometrial Hyperplasia; Gynecologic Cancer; Endometrial Cancer
• Interventions: Procedure: Hysteroscopic uterine resection

• Registration Number: NCT04362046
• Lead Sponsor: Vancouver Coastal Health Research Institute

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.

Detailed Description

Endometrial cancer (EC) is the most common gynecological cancer among Canadian women. This cancer often arises from a precursor lesion called atypical endometrial hyperplasia (AH). Hysterectomy is the most effective treatment for EC and AH. It is well recognized that EC may be diagnosed in younger women of child-bearing age. The diagnosis of EC or AH in these younger women is devastating as a hysterectomy is frequently required. Though some of these women respond to high-dose progestin treatment, the failure rate is high (60%), necessitating surgery. Recent case series show that some women with AH and early EC can be treated by resecting the precursor lesion of the early cancerous area in the uterus by hysteroscopy without the need for hysterectomy. The fertility-sparing approach is outlined in this research protocol.This is a multidisciplinary research project with input from gynaecologic oncology, general gynaecology, reproductive endocrinology and infertility, and pathology. Our hypothesis is that hysteroscopic resection (HR) is a safe and effective treatment for AH or EC in women who want to preserve their fertility and have not been successfully treated using progestin therapy. Patients will be closely monitored to ensure that this is a safe and effective treatment option.

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Study Start: 2020-11-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-20
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hysteroscopic uterine resection	Hysteroscopic uterine resection	This is a prospective single-arm surgical intervention trial.

Primary Outcome Measures

Name	Time	Method
Overall conception rate	3 years post-resection	live births / all women participating in study, including those who failed hysteroscopic resection and have a hysterectomy
Conception rate of women attempting pregnancy	3 years post-resection	live births / women attempting pregnancy
Local disease control rate (short-term failure of hysteroscopic resection)	3 months post-resection	Patients with persisting atypical hyperplasia or Grade I endometrial cancer / patients treated with hysteroscopic resection
Distant disease control rate (long-term failure of hysteroscopic resection)	3 years post-resection	patients developing distant recurrence / patients treated with hysteroscopic resection

Secondary Outcome Measures

Name	Time	Method
Complications/side-effects	3 years post-resection	The investigators will tabulate complications/side-effects of the procedure such as the rate of uterine perforation, uterine adhesion, procedure infection, and others.

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada