Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia (FETCH)
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|ClinicalTrials.gov Identifier: NCT04362046|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Hyperplasia Endometrial Cancer Gynecologic Cancer||Procedure: Hysteroscopic uterine resection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer|
|Actual Study Start Date :||November 15, 2020|
|Estimated Primary Completion Date :||July 2028|
|Estimated Study Completion Date :||July 2028|
Experimental: Hysteroscopic uterine resection
This is a prospective single-arm surgical intervention trial.
Procedure: Hysteroscopic 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.
- Conception rate of women attempting pregnancy [ Time Frame: 3 years post-resection ]live births / women attempting pregnancy
- Overall conception rate [ Time Frame: 3 years post-resection ]live births / all women participating in study, including those who failed hysteroscopic resection and have a hysterectomy
- Local disease control rate (short-term failure of hysteroscopic resection) [ Time Frame: 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) [ Time Frame: 3 years post-resection ]patients developing distant recurrence / patients treated with hysteroscopic resection
- Complications/side-effects [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362046
|Contact: Neeraj Mehra, MDfirstname.lastname@example.org|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Janice Kwon, MD 604-875-4268 email@example.com|
|Principal Investigator: Neeraj Mehra, MD|
|Principal Investigator:||Mark Carey, MD||Vancouver Coastal Health|