Weight-loss surgery with hormone treatment for early womb lining cancer in young women
Tests bariatric surgery plus progestin therapy in women with obesity and early endometrial disease.
Plain-language title generated from the registry record
Registry title: Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Key facts
- Where
- Toronto, CanadaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 41 with obesity and early womb lining cancer or pre-cancer who wish to keep their fertility. It tests weight loss surgery together with hormone treatment.
- Age
- 18 to 41 years
- Sex
- Women only
- Disease stage
- Grade 1 endometrioid endometrial cancer or complex atypical hyperplasia. Clinical stage 1 disease, with no spread beyond the uterus on imaging (MRI, CT).
- Earlier treatment
- No previous major upper abdominal surgery, such as earlier bariatric surgery, splenectomy, partial gastrectomy, liver resection or bowel resection. Appendectomy, cholecystectomy, hernia repair and caesarean section are acceptable. No current weight loss medication. People taking GLP-1 agonists for diabetes can still join.
- Biomarker or test result
- BMI of 35 or more. No high grade or p53 endometrial cancer.
Main reasons for not taking part
- Cancer growing into the womb muscle or spread outside the uterus on imaging
- Other cancer in the past, unless fully treated with no disease for more than 5 years
- Currently pregnant
- Smoking within the last 6 months, or an active substance use disorder
- Medical illness with organ damage, or a current untreated or severe psychiatric problem
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 41 years old?
Source: NCT04008563, who can take part
Where in Canada
- Princess Margaret HospitalToronto, CanadaContact: Tara ZadTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT04008563
- Record updated
- 14 March 2025
- Original description
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.Read full original descriptionShow less
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
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.
Inclusion: 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: 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; 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; History of other malignancies, except if curatively treated with no evidence of disease for > 5 years; 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.