Actively Recruiting
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Led by University Health Network, Toronto · Updated on 2025-03-14
36
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.
CONDITIONS
Official Title
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI 65 35
- Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
- Clinical stage 1 disease with no spread beyond the uterus shown by MRI or CT imaging
- ECOG performance status less than 2
- Desire to preserve fertility
- No contraindications to progestin intrauterine device (IUD)
- Signed informed consent form
You will not qualify if you...
- Signs of myometrial invasion or disease outside the uterus on imaging
- High grade or p53 endometrial cancer
- History of other cancers unless cured and no disease for over 5 years
- Previous major upper abdominal surgery (excluding appendectomy, cholecystectomy, hernia repair, or cesarean section)
- Current use of weight loss medications (except GLP-1 agonists like OZEMPIC for diabetes)
- Contraindications to sleeve gastrectomy
- Medical conditions causing end-organ dysfunction
- Unable to understand or participate in informed consent
- Currently pregnant
- Smoking within the last 6 months
- Active substance use disorder
- Untreated or severe psychiatric illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
T
Tara Zad
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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