NCT04008563Recruiting
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 3 Jul 2019
- Start date
- 14 May 2021
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Endometrial cancer
- NCT number
- NCT04008563
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 14 May 2021 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Evidence of myometrial invasion or extra-uterine disease on imaging
- High grade or p53 endometrial cancer
- 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.
- Active substance use disorder
- Current untreated or severe psychiatric issue
Age
- History of other malignancies, except if curatively treated with no evidence of disease for \> 5 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 41 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.