Cervical Intraepithelial NeoplasiaPhase 1NCT06191133
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
A Phase 1 study testing Fenofibrate, Cervical Conization and Hysterectomy in people with Cervical Intraepithelial Neoplasia and Invasive Cervical Cancer, run by Lindsay Ferguson, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Invasive Cervical Cancer
- What is being tested?
- Fenofibrate, Cervical Conization and Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2024to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Lindsay A Ferguson, MD, 216-844-3954, lindsay.ferguson@uhhospitals.org
About this study
Official title: Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
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.
- Being tested
- Fenofibrate, Cervical Conization, Hysterectomy, Chemoradiation
- Keywords
- Fenofibrate
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Also called Antara, Fenoglide, Lipofen, Tricor
Fenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use.
Cervical ConizationProcedure or surgery
Cold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix
HysterectomyProcedure or surgery
In a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed.
ChemoradiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Fenofibrate; Procedure: Cervical Conization |
| 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 Receives: Drug: Fenofibrate; Procedure: Hysterectomy; Radiation: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in p53 levels
Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery
Measured: 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
Measured: Up to six weeks after study enrollment
Secondary outcomes (1)
Fenofibrate tolerability
Assess tolerability of fenofibrate by comparing lab values at baseline to values at conclusion of treatment
Measured: Up to six weeks after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindsay Ferguson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lindsay Ferguson, MD, Case Comprehensive Cancer Center
- Investigators
- Lindsay Ferguson, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191133
- Sponsor's protocol ID
- CASE3822
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Window of Opportunity Trial of Fenofibrate in Patients With High-grade Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT06191133
- Acronym / sponsor ID
- CASE3822
- Keywords
- Fenofibrate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Lindsay Ferguson, MDUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excisional procedure + Fenofibrate | Experimental | Drug: Fenofibrate, Procedure: Cervical ConizationParticipants 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 | Drug: Fenofibrate, Procedure: Hysterectomy, Radiation: ChemoradiationParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenofibrateAlso: Antara, Fenoglide, Lipofen, TricorFenofibrate is an FDA approved drug for cardiovascular indications and have decades of data supporting a favorable safety profile event with chronic use. | Drug | Excisional procedure + Fenofibrate, Hysterectomy or chemoradiation + fenofibrate |
| Cervical ConizationCold knife conization or loop electrosurgical excision to remove cells and tissue in the cervix | Procedure or surgery | Excisional procedure + Fenofibrate |
| HysterectomyIn a hysterectomy, the uterus, cervix, both ovaries, both fallopian tubes, and nearby tissue are removed. | Procedure or surgery | Hysterectomy or chemoradiation + fenofibrate |
| ChemoradiationChemotherapy 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. | Radiation | Hysterectomy or chemoradiation + fenofibrate |
Primary outcome
Change in p53 levels
Time frame: Up to six weeks after study enrollment
Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery
Change in tumor metabolic status
Time frame: Up to six weeks after study enrollment
Changes in tumor metabolic status from initial biopsy to repeat sampling at the time of surgery evaluated via immunohistochemical testing
1 secondary outcome
Fenofibrate tolerability
Time frame: Up to six weeks after study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsay Ferguson, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fenofibrate, Cervical Conization and Hysterectomy in people with Cervical Intraepithelial Neoplasia and Invasive Cervical Cancer, run by Lindsay Ferguson, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay A Ferguson, MD (216-844-3954, lindsay.ferguson@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in p53 levels (time frame: Up to six weeks after study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.