Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Endometrial Cancer
  • Endometrial Hyperplasia
  • Gynecologic Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 19 years and 39 years
Gender
Only males

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 w...

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.

Tracking Information

NCT #
NCT04362046
Collaborators
  • University of British Columbia
  • Gynecologic Cancer Initiative - Clinical Trials Group (GCI-CTG)
Investigators
Principal Investigator: Mark Carey, MD Vancouver Coastal Health