Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Location contact
Victoria Bae-Jump, M.D., PhD
CONTACT
Victoria Bae-Jump, M.D., PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07065552
LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen.
The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.
Interested in participating?
Request Info18 year and older
Female
Interventional
Early Phase 1
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Victoria Bae-Jump, M.D., PhD
CONTACT
Victoria Bae-Jump, M.D., PhD
PRINCIPAL_INVESTIGATOR
The primary objective is to determine if tirzepatide decreases proliferation in the tumors of EC patients. The effect of tirzepatide on the endometrium of 20 obese women with EC will be evaluated by comparing each patient's endometrial biopsy before tirzepatide treatment to their post-treatment hysterectomy specimen, through a pre- operative window study. These women will begin tirzepatide treatment for 4 weeks prior to standard-of-care (SOC) surgery. Subjects will have a single end-of-treatment visit 4 weeks after completing therapy and will be followed for 24 months via medical record abstraction to monitor weight loss maintenance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tirzepatide will be administered once weekly, subcutaneously, and patients will be taught how to administer this drug at home. Patients will be started on a dose of 5 mg tirzepatide weekly for four weeks prior to surgical staging. .
Time frame: Baseline - Up to 6 weeks
Change in Proliferation will be determined by immunohistochemical ( Ki-67 staining) analysis pre- (baseline) and post-tirzepatide treatment hysterectomy samples (at the time of surgery and end of treatment). The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (>30%): Fast-growing, potentially more aggressive.
Time frame: Baseline - Up to 6 weeks
Diabetes status (yes/no) will be documented before and after tirzepatide treatment using the medical records and diabetes diagnostic criteria.
Time frame: Baseline - Up to 6 weeks
HgbA1C level will be documented pre- and post-tirzepatide treatment.
Time frame: Baseline - Up to 6 weeks
The waist-to-hip ratio will be documented pre- and post-tirzepatide treatment.
Time frame: Baseline - Up to 6 weeks
Body Mass Index (measured by dividing weight in kgs by height in meters) will be documented pre- and post-tirzepatide treatment.
Time frame: Baseline - Up to 6 weeks
Serum levels of leptin, adiponectin, CRP, IL-1B, VEGFA, CCL3, IL-23, TNF-A, IL-6 pre- and post-tirzepatide treatment will be documented.
Time frame: Baseline - Up to 6 weeks
Serum levels of estradiol, estrone, and sex hormone binding globulin pre- and post-tirzepatide treatment will be documented.
Time frame: Baseline - Up to 6 weeks
Serum levels of lipid panel pre- and post-tirzepatide treatment will be documented.
Time frame: Baseline - Up to 6 weeks
Serum levels of fasting insulin pre- and post-tirzepatide treatment will be documented.
Time frame: Baseline - Up to 6 weeks
Serum levels of Insulin-like Growth Factor 1 (IGF-1 ) pre- and post-tirzepatide treatment will be documented. IGF-1 is a hormone similar in structure to insulin and plays a crucial role in growth and development. Here are the key points about IGF-1:
Time frame: Baseline - Up to 6 weeks
Serum glucose levels pre- and post-tirzepatide treatment will be documented.
Time frame: Baseline - Up to 6 weeks
Serum liver function panel pre- and post-tirzepatide treatment will be documented. The same serum sample will be used to measure to determine Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma-Glutamyl Transferase (GGT) levels. All participants will be analyzed using this single sample, and results will be reported in Units per Liter (U/L) for each enzyme.
Time frame: Baseline - Up to 6 weeks
Apoptosis will be assessed via immunohistochemistry before and after tirzepatide treatment.
Time frame: Baseline - Up to 6 weeks
RNA sequence will be assessed via immunohistochemistry in endometrial carcinoma specimen before and after tirzepatide treatment.
Contact information is provided by the study sponsor or research team.
Emmie Cole
CONTACT
Luz Cuaboy
CONTACT
UNC Lineberger Comprehensive Cancer Center
Other
A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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