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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06191133
Other study ID # CASE3822
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2024
Est. completion date May 31, 2025

Study information

Verified date April 2024
Source Case Comprehensive Cancer Center
Contact Lindsay A Ferguson, MD
Phone 216-844-3954
Email lindsay.ferguson@uhhospitals.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date May 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Fenofibrate
Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.
Procedure:
Cervical Conization
Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
Hysterectomy
In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.
Radiation:
Chemoradiation
Chemotherapy uses anti cancer (cytotoxic) drugs to destroy cancer cells. The drugs circulate throughout the body in the bloodstream. Radiotherapy uses high energy waves similar to x-rays to kill cancer cells.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lindsay Ferguson, MD

Outcome

Type Measure Description Time frame Safety issue
Primary Change in p53 levels Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery Up to six weeks after study enrollment
Primary Change in tumor metabolic status Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing Up to six weeks after study enrollment
Secondary Fenofibrate tolerability Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment Up to six weeks after study enrollment
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