RecruitingNot ApplicableNCT04008563

Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium


Sponsor

University Health Network, Toronto

Enrollment

36 participants

Start Date

May 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 41 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether bariatric (weight loss) surgery can improve the effectiveness of hormonal treatment (a progesterone-releasing IUD) for women with early-stage endometrial (uterine) cancer or a pre-cancerous condition called atypical hyperplasia, who want to preserve their fertility rather than have a hysterectomy. **You may be eligible if...** - Your BMI is 35 or higher - You have been diagnosed with grade 1 endometrioid endometrial cancer or complex atypical hyperplasia (a pre-cancerous uterine condition) - Your cancer is early-stage with no evidence of spread beyond the uterus on imaging - You want to preserve your ability to have children - You have no contraindications to a progesterone IUD **You may NOT be eligible if...** - Your cancer has invaded the uterine muscle wall or spread outside the uterus - You have a high-grade or aggressive type of endometrial cancer - You have had major upper abdominal surgery (such as previous bariatric surgery or liver resection) - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBariatric Surgery

Patients who are randomized to the intervention group will receive a progestin intrauterine device and be referred for bariatric service to undergo bariatric surgery within 3 months of their study consent.


Locations(1)

Princess Margaret Hospital

Toronto, Ontario, Canada

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NCT04008563


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