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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 41
Healthy Volunteers: f
View:

• BMI ≥ 35

• Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia

• Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by imaging performed (MRI, CT)

• ECOG status \<2

• Desire for fertility preservation

• No contraindications to progestin intrauterine device (IUD)

• Have signed an approved informed consent form

Locations
Other Locations
Canada
Princess Margaret Hospital
RECRUITING
Toronto
Contact Information
Primary
Tara Zad
Tara.Zad@uhn.ca
416-946-4501
Time Frame
Start Date: 2021-05-14
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 36
Treatments
Experimental: Bariatric Surgery and Progestin Intrauterine Device
This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
No_intervention: Progestin Intrauterine Device Alone
This group will receive a progestin intrauterine device alone.
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov