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Fenofibrate for Cervical Pre-Cancer and Cancer

This study is looking into how Fenofibrate, a cholesterol-lowering medication, might help treat cervical intraepithelial neoplasia (pre-cancerous changes in the cervix) and invasive cervical cancer. Researchers believe Fenofibrate can help a protein called p53, which normally prevents tumors, work better and change how HPV-positive tumors grow. You may be able to join if you are a woman aged 18 or older with confirmed high-grade dysplasia or cervical cancer and are eligible for standard treatments like cervical conization (a procedure to remove abnormal cells), hysterectomy (removal of the uterus), or chemoradiation (chemotherapy and radiation). The study will examine tissue samples to see if Fenofibrate affects these conditions. The goal is to understand if Fenofibrate can be a new way to treat these HPV-related cervical conditions.

Study design
This is an interventional study with a planned enrollment of 24 participants. The phase of the study is not specified.
What's involved
You would undergo standard treatments like cervical conization, hysterectomy, or chemoradiation. Researchers will examine collected tissue samples to study the effects of Fenofibrate.
Compensation
Not stated in the trial record.
Follow-up
Changes in p53 levels and tumor metabolic status will be measured up to six weeks after study enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06191133

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lindsay Ferguson, MD
~24 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:FenofibrateCervical ConizationHysterectomyChemoradiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in p53 levels
Measured over Up to six weeks after study enrollment
+1 more outcome measured

Conditions

Cervical Intraepithelial Neoplasia
Invasive Cervical Cancer

Explore related trials

Cervical CarcinomaCervical Intraepithelial Neoplasia

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Lindsay Ferguson, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Who to contact

Lindsay A Ferguson, MD
[email protected]
216-844-3954
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in p53 levelsUp to six weeks after study enrollment

    Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery

  • Change in tumor metabolic statusUp to six weeks after study enrollment

    Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing