Recruiting

Bariatric Surgery

Sponsor:

University Health Network, Toronto

Code:

NCT04008563

Conditions

Endometrial Cancer

Atypical Hyperplasia

Bariatric Surgery Candidate

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Not accepted

Interventions

Bariatric Surgery

Study Details

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.

Conditions

Endometrial Cancer

Atypical Hyperplasia

Bariatric Surgery Candidate

Study ID

NCT04008563

Start date

May 14, 2021

Status verified date

Mar, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Recruitment Rate [ Time Frame: Year 5 ]

Central Contacts and Locations

Central contacts

Tara Zad

416-946-4501Tara.Zad@uhn.ca

Locations

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 14, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-03-14.