Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lindsay Ferguson, MD
• Treatments: Fenofibrate

Criteria

Inclusion Criteria:

• Subjects must have histologically or cytologic confirmed high grade dysplasia or cervical cancer. Histologic types include squamous cell, adenocarcinoma or adenosquamous cell carcinoma.

• Subjects must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation

• Subjects receiving treatment at University Hospital Seidman Cancer Center

• Age ≥ 18 years

• Subjects must be English speaking

• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Subjects with a history of hepatic or renal insufficiency

• Subjects that are pregnant or breast feeding because of potential due to unknown risk to developing fetus/infant. Please note: Patients are actively screened for pregnancy prior to diagnostic cervical colposcopy procedures and screened again prior to treatment of surgical pathology.