Using Fenofibrate to treat cervical cancer and dysplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of Fenofibrate, a cholesterol-lowering medication, on patients with cervical intraepithelial neoplasia and invasive cervical carcinoma. Researchers aim to understand how Fenofibrate can restore normal p53 function and alter the metabolism of HPV-positive tumors to inhibit their growth. The study will involve examining tissue samples and analyzing various genes and proteins to assess the drug's impact on these conditions. Participants will undergo surgical management or chemoradiation as part of their treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must have histologically or cytologic confirmed high grade dysplasia or cervical cancer. Histologic types include squamous cell, adenocarcinoma or adenosquamous cell carcinoma.
* Participants must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation
* Age ≥ 18 years
* Normal liver function (AST, ALT, bilirubin within institutional normal limits).
* Participants must be English speaking
* Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants with active liver disease, including primary biliary cirrhosis and unexplained, liver function abnormality
* Participants with severe kidney impairment (CrCl ≤30 mL/min calculated using Cockcroft-Gault), or end-stage kidney disease on dialysis
* Participants with preexisting gallbladder disease including active gallstones
* Known hypersensitivity to fenofibrate or fenofibric acid
* Participants that are pregnant or breast feeding due to unknown risk to developing fetus/infant. Please note: Participants of child-bearing potential (have had menses within the past year or have not had total hysterectomy) are actively screened for pregnancy prior to diagnostic procedures and screened again prior to treatment.

Where it's running

• University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Lindsay Ferguson, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
• Study coordinator: Lindsay A Ferguson, MD
• Email: lindsay.ferguson@uhhospitals.org
• Phone: 216-844-3954

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.