NCT06191133 Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
| NCT ID | NCT06191133 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Lindsay Ferguson, MD |
| Condition | Cervical Intraepithelial Neoplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-11-20 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Lindsay Ferguson, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06191133 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Intraepithelial Neoplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06191133 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06191133 currently recruiting?
Yes, NCT06191133 is actively recruiting participants. Contact the research team at lindsay.ferguson@uhhospitals.org for enrollment information.
Where is the NCT06191133 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06191133 clinical trial?
NCT06191133 is sponsored by Lindsay Ferguson, MD. The principal investigator is Lindsay Ferguson, MD at University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center. The trial plans to enroll 24 participants.