Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Carcinoma in Situ

Uterine Cervical Dysplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Lipid Regulating Agents

All Drugs and Chemicals

Fenofibrate

Hypolipidemic Agents

Antimetabolites

Participants with high-grade dysplasia will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their excisional procedure

Participants with invasive cervical cancer will receive 200mg of Fenofibrate starting on the day of enrollment and will continue the drug administration daily for 2-4 weeks +/- 7 days until their definitive hysterectomy or chemoradiation

Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.

Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix

Cervical Conization

In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.

Hysterectomy

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.

Chemoradiation

Lindsay A Ferguson, MD

Lindsay Ferguson, MD

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.

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

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

Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery

Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing

Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment

Principal Investigator

Infections

Symptoms and General Pathology

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Papilloma

Persistent Infection

Disease Attributes

Neoplasms, Squamous Cell

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

The patients who meet the inclusion criteria will receive diagnostic cervical conization for pathological examinations. Then they will be followed up for at least two years with every six months' return to our clinics to test HPV and colposcopy if necessary.

For the patients who met the inclusion criteria, the gynecologists perform cervical conization and pathological examinations. Then the patients will be followed-up for at least two years with the tests of cervical TCT \& HPV, and colposcopy if necessary. The data will be analyzed and see if the patients with high risk factors benefit from the surgery or not.

diagnostic cervical conization

Shuang Li, M.D

Dongli Kong, M.D

For the patients with cervical persistent infection or integration of HPV, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.

For the patients with cervical persistent infection or integration of human papillomavirus, the incidence of suffering cervical cancer or percancerous lesions increases. As the biopsy guided by colposcopy might miss some lesions, the cervical conization plays a role for the patients with high risk factors to diagnose the related cervical diseases. In this study, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.

Diagnostic Cervical Conization for Persistent Infection or Integration of HPV

A Study of the Value of Diagnostic Cervical Conization for Persistent Infection or Integration of Human Papillomavirus

Every six month, we will check if there is a new subject recruited in the study and update the data.

The pathological examinations of the cervical conization might discover some concealed cervical cancer or precancerous lesions which could not be discovered by biopsy guided by colposcopy.

After the cervical conizations, the patients will be arranged for follow-up every six months and HPV will be tested to see if the virus is cleared or not

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma	NCT06191133	Cervical Intrae... Invasive Cervic...	Fenofibrate Cervical Coniza... Hysterectomy Chemoradiation	18 Years -	Case Comprehensive Cancer Center
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma	NCT06191133	Cervical Intrae... Invasive Cervic...	Fenofibrate Cervical Coniza... Hysterectomy Chemoradiation	18 Years -	Case Comprehensive Cancer Center
Diagnostic Cervical Conization for Persistent Infection or Integration of HPV	NCT05510830	Human Papilloma... Human Papilloma... Cervical Intrae... Cervical Cancer Cervical Coniza...	diagnostic cerv...	25 Years - 70 Years	Tongji Hospital

Spots Global Cancer Trial Database for cervical conization