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NCT06191133 · ClinicalTrials.gov registry record · Phase 1
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
A Phase 1 study of Cervical Intraepithelial Neoplasia and Invasive Cervical Cancer, sponsored by Lindsay Ferguson, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06191133: Recruiting Phase 1 study of Cervical Intraepithelial Neoplasia and Invasive Cervical Cancer, sponsored by Lindsay Ferguson, MD.
NCT06191133 is a Phase 1 study of Cervical Intraepithelial Neoplasia and Invasive Cervical Cancer that is actively recruiting participants, run by Lindsay Ferguson, MD. The registered enrollment target is 24 participants, below the 267-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06191133, a Phase 1 study of Cervical Intraepithelial Neoplasia and Invasive Cervical Cancer, is actively recruiting participants, sponsored by Lindsay Ferguson, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Changes in p53 levels from initial biopsy to repeat sampling at the time of surgery
Conditions Studied
Interventions
- RADIATION Chemoradiation
- DRUG Fenofibrate
- PROCEDURE Cervical Conization
- PROCEDURE Hysterectomy
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-11-20 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
What NCT06191133 shows while recruiting
NCT06191133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 267-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Cervical Intraepithelial Neoplasia appearing as the primary indexed condition, and to 4 interventions - of which Chemoradiation is the first listed.
NCT06191133 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06191133 about?
NCT06191133 is a clinical study titled "Fenofibrate in Patients With 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 under...
What is the current status of trial NCT06191133?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-11-20. Estimated completion is 2026-11-30.
What conditions does trial NCT06191133 study?
This clinical trial studies the following conditions: Cervical Intraepithelial Neoplasia, Invasive Cervical Cancer.
What interventions are being tested in trial NCT06191133?
The interventions under investigation include: Chemoradiation (RADIATION), Fenofibrate (DRUG), Cervical Conization (PROCEDURE), Hysterectomy (PROCEDURE).
Who is sponsoring clinical trial NCT06191133?
This trial is sponsored by Lindsay Ferguson, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06191133 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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