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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Excisional procedure + Fenofibrate | Experimental | 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 |
|
| Hysterectomy or chemoradiation + fenofibrate | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug | Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay A Ferguson, MD | Contact | 216-844-3954 | lindsay.ferguson@uhhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay Ferguson, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D019092 | Conization |
| D007044 | Hysterectomy |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Cervical Conization | Procedure | Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix |
|
| Hysterectomy | Procedure | In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed. |
|
| Chemoradiation | Radiation | 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. |
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |