Actively Recruiting
Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Led by Lindsay Ferguson, MD · Updated on 2025-10-02
24
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how Fenofibrate, a cholesterol-lowering drug, might affect HPV-positive cervical cancers and cervical dysplasia. Early research suggests that Fenofibrate can restore the tumor-preventing function of p53 and change tumor metabolism to stop tumor growth. This Phase 1 trial aims to understand Fenofibrate's impact on these cervical conditions by analyzing tissue samples and investigating related genes and proteins. Participants with high-grade cervical dysplasia will take 200mg of Fenofibrate daily starting on the day they join the study and continue for 2 to 4 weeks until their excisional procedure. Those with invasive cervical cancer will also take 200mg daily for 2 to 4 weeks until they undergo hysterectomy or chemoradiation treatment. The study is non-randomized and open-label, with all participants receiving Fenofibrate along with their planned surgical or chemoradiation procedures. During the study, researchers will monitor changes in p53 protein levels and tumor metabolism up to six weeks after enrollment. They will also assess how well Fenofibrate is tolerated. Participants will provide tissue samples for analysis, and their liver function will be checked to ensure safety. The total study period for each participant is up to six weeks, including treatment and follow-up assessments.
CONDITIONS
Brief Title
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed high-grade cervical dysplasia or cervical cancer (squamous cell, adenocarcinoma, or adenosquamous carcinoma).
- Participants must be eligible for surgical treatment with LEEP, cold knife conization, hysterectomy, or chemoradiation.
- Age 18 years or older.
- Normal liver function tests within institutional limits.
- Participants must be English speaking.
- Ability and willingness to sign informed consent.
You will not qualify if you...
- Active liver disease or unexplained liver function abnormalities.
- Severe kidney impairment with creatinine clearance ≤30 mL/min or dialysis.
- Preexisting gallbladder disease or active gallstones.
- Known allergy to fenofibrate or fenofibric acid.
- Pregnant or breastfeeding women.
- Participants of child-bearing potential are screened for pregnancy before procedures and treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 weeks plus or minus 7 days
Participants receive 200mg of Fenofibrate daily starting on the day of enrollment and continue for 2 to 4 weeks plus or minus 7 days until their excisional procedure, hysterectomy, or chemoradiation.
Daily drug administration with 1 to 2 visits depending on the procedure timing
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
L
Lindsay A Ferguson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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