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Clinical Trials in Canada / NCT04008563
Recruiting Not applicable

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

NCT04008563 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2021-05-14
Last updated
2025-03-14

Condition(s) studied

Endometrial CancerAtypical HyperplasiaBariatric Surgery Candidate

Investigational drug(s) / intervention(s)

Bariatric Surgery

Bariatric 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.

Study 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
FEMALE
Min age
18 Years
Max age
41 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Evidence of myometrial invasion or extra-uterine disease on imaging * High grade or p53 endometrial cancer * History of other malignancies, except if curatively treated with no evidence of disease for \> 5 years * Previous major upper abdominal surgery (ex. previous bariatric surgery, splenectomy, partial gastrectomy, liver resection, bowel resection). Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion. * Current use of weight loss medication. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes will not be excluded. * Contraindications to sleeve gastrectomy * Medical co-morbidity with end-organ dysfunction * Unable to understand and participate in the informed consent process * Currently pregnant * Active smoking in ≤6 months * Active substance use disorder * Current untreated or severe psychiatric issue

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Princess Margaret Hospital Toronto Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04008563 on ClinicalTrials.gov ↗ ← All trials in Canada