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RECRUITING
NCT06191133
PHASE1

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Sponsor: Lindsay Ferguson, MD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-11-20

Completion Date

2026-11-30

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DRUG

Fenofibrate

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

PROCEDURE

Cervical Conization

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

PROCEDURE

Hysterectomy

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

RADIATION

Chemoradiation

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.

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States