RecruitingPhase 1NCT06191133

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Sponsor

Lindsay Ferguson, MD

Enrollment

24 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Cervical Intraepithelial Neoplasia Invasive Cervical Cancer

Summary

Normally, p53 helps prevent tumors from forming in the body. Early studies have shown that Fenofibrate, a cholesterol-lowering drug, can restore normal function to p53 and can change the metabolism of HPV-positive tumors in a way that stops the growth of tumors. The purpose of this study is to understand how Fenofibrate can be used to treat HPV-positive cervical cancers and cervical dysplasia. Researchers will examine collected tissue samples and investigate various genes and proteins to see whether Fenofibrate has an effect on HPV-positive cervical cancers and cervical dysplasia.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether fenofibrate (a drug commonly used to lower cholesterol) can slow the growth of abnormal cervical cells or early cervical cancer before or alongside standard treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-grade abnormal cervical cells (dysplasia) or cervical cancer confirmed by biopsy - You are eligible for surgery (LEEP, cone biopsy, or hysterectomy) or chemoradiation - Your liver function is normal - You can read and speak English **You may NOT be eligible if...** - You have active liver disease or unexplained elevated liver tests - You have severe kidney impairment or are on dialysis - You have known gallbladder disease or gallstones - You are allergic to fenofibrate - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFenofibrate

Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.

PROCEDURECervical Conization

Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix

PROCEDUREHysterectomy

In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.

RADIATIONChemoradiation

Chemotherapy uses anti cancer (cytotoxic) drugs to destroy cancer cells. The drugs circulate throughout the body in the bloodstream. Radiotherapy uses high energy waves similar to x-rays to kill cancer cells.