Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Официальное название

Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Обзор

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.

Вмешательства

• Препарат Fenofibrate
  Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.
• Процедура Cervical Conization
  Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
• Процедура Hysterectomy
  In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.
• Лучевая терапия 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.

Первичные конечные точки

• Change in p53 levels [Срок оценки: Up to six weeks after study enrollment]
• Change in tumor metabolic status [Срок оценки: Up to six weeks after study enrollment]

Вторичные конечные точки (1)

• Fenofibrate tolerability [Срок оценки: Up to six weeks after study enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland

Идентификаторы

NCT: NCT06191133 · CASE3822

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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