NCT04008563 Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
| NCT ID | NCT04008563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2021-05-14 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2021-05-14 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Sarah E Ferguson, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT04008563 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 41 Years, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04008563 currently recruiting?
Yes, NCT04008563 is actively recruiting participants. Contact the research team at Tara.Zad@uhn.ca for enrollment information.
Where is the NCT04008563 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04008563 clinical trial?
NCT04008563 is sponsored by University Health Network, Toronto. The principal investigator is Sarah E Ferguson, MD at University Health Network, Toronto. The trial plans to enroll 36 participants.
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