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Procedure

Fertility-Sparing Surgery for Endometrial Cancer (FETCH Trial)

N/A
Recruiting
Led By Mark Carey, MD
Research Sponsored by Vancouver Coastal Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate duration of progesterone therapy: 6 months
Failure of progestin therapy defined as unsuccessful eradication of hyperplasia or cancer in the uterus, or intolerance to the side effects
Must not have
Women who are not able to provide informed consent
The diagnosis of another cancer or medical condition that would interfere with the assessment of the hysteroscopic surgery success rates
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post-resection
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to remove early stage endometrial cancer without harming fertility.

Who is the study for?
This trial is for women under 40 with early-stage endometrial cancer or atypical hyperplasia who haven't improved with hormone therapy and want to keep their fertility. They should have less than a third of the uterus affected, no severe health issues that could complicate surgery, and a reasonable chance to conceive as assessed by a fertility specialist.
What is being tested?
The study tests hysteroscopic resection—a surgical procedure using an instrument inserted through the vagina to remove abnormal tissue from the uterus—in patients desiring fertility preservation after unsuccessful hormone treatment for certain uterine conditions.
What are the potential side effects?
While specific side effects are not listed, typical risks of hysteroscopic surgery may include bleeding, infection, injury to the uterus or surrounding organs, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on progesterone therapy for at least 6 months.
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Progestin therapy did not work for my uterine condition or I couldn't tolerate its side effects.
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My biopsy shows early-stage endometrial cancer with limited spread.
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My biopsy shows I have atypical endometrial hyperplasia.
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I am under 40 years old.
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I don't have major health issues that would make surgery risky.
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My MRI shows minimal invasion of the muscle layer of my uterus.
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I have taken the required dose of progesterone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand and give consent for my treatment.
Select...
I don't have any other cancers or conditions that could affect surgery outcomes.
Select...
My Grade I endometrial cancer affects more than one-third of the uterus.
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I am 40 years old or older.
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I am a woman without confirmed low-grade endometrioid carcinoma or atypical hyperplasia.
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My endometrial cancer is grade 2 or 3, either endometrioid or non-endometrioid type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post-resection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post-resection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Conception rate of women attempting pregnancy
Distant disease control rate (long-term failure of hysteroscopic resection)
Local disease control rate (short-term failure of hysteroscopic resection)
+1 more
Secondary study objectives
Complications/side-effects

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hysteroscopic uterine resectionExperimental Treatment1 Intervention
This is a prospective single-arm surgical intervention trial.

Find a Location

Who is running the clinical trial?

University of British ColumbiaOTHER
1,466 Previous Clinical Trials
2,485,426 Total Patients Enrolled
Vancouver Coastal Health Research InstituteLead Sponsor
26 Previous Clinical Trials
5,160 Total Patients Enrolled
Mark Carey, MDPrincipal InvestigatorVancouver Coastal Health

Media Library

Hysteroscopic uterine resection (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04362046 — N/A
Endometrial Hyperplasia Research Study Groups: Hysteroscopic uterine resection
Endometrial Hyperplasia Clinical Trial 2023: Hysteroscopic uterine resection Highlights & Side Effects. Trial Name: NCT04362046 — N/A
Hysteroscopic uterine resection (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04362046 — N/A
~14 spots leftby Jul 2028
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