Status:
NOT_YET_RECRUITING
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
Lead Sponsor:
University Health Network, Toronto
Conditions:
Endometrial Cancer
Atypical Hyperplasia
Eligibility:
FEMALE
18-41 years
Phase:
PHASE2
Brief Summary
The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesit...
Detailed Description
The research aims to answer the question: "Does the addition of a Glucose-dependent Insulinotropic Polypeptide (GIP)/Glucagon-like Peptide-1 (GLP-1) co-agonist to standard progestin treatment lead to ...
Eligibility Criteria
Inclusion
- BMI ≥ 27
- Diagnosis of grade 1 or 2 endometrioid endometrial cancer or atypical hyperplasia made by either endometrial biopsy or dilation and curettage
- For those with endometrial cancer, clinical FIGO 2009 stage 1A disease without evidence of metastatic disease beyond the uterus and no myometrial invasion by MRI or CT
- ECOG status \<2
- Desire for fertility preservation
- Ability to understand and willing to sign a written informed consent document
Exclusion
- Evidence of myometrial invasion or extra-uterine disease on imaging
- High grade or p53 mutated (p53mut) endometrial cancer
- Estrogen receptor negative endometrial cancer (positivity defined as moderate/strong staining\>10%)
- Mismatch repair deficient (MMRd) endometrial cancer
- History of other malignancies except if curatively treated with no evidence of disease for \>5 years
- Previous surgical treatment of obesity
- Current use of weight loss medication (no use in last 2 months)
- Medical co-morbidity with end-organ dysfunction
- Contraindications to pIUD or tirzepatide.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2032
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT06073184
Start Date
August 1 2025
End Date
February 1 2032
Last Update
June 10 2025
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