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New treatment option for Endometrial Cancer
Official title Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
ClinicalTrials.gov ID: NCT04008563
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 41, women only
You may be able to join if
- 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
You likely can't join if
- 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)...
- Current use of weight loss medication. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes...
- Contraindications to sleeve gastrectomy
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 41 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.