Clinical Research Directory

Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV

The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV. While there is consensus that women testing positive for HPV 16 and/or 18 should be immediately managed and treated, optimal management strategies for women with other hrHPV types (non-16/18) are not well defined. This prospective cohort study will enroll WLWH undergoing cervical cancer screening using primary HPV testing. Women will self-collect vaginal specimens for hrHPV testing using the Abbott Alinity m HPV assay, which provides extended HPV genotyping and a proxy for HPV viral load based on cycle threshold (CT) values. Women with hrHPV detected will return for further evaluation and treatment as indicated. A subset of women will return at Month 6 for repeat evaluation. The study will evaluate feasibility for a future trial by examining recruitment, retention, return for evaluation, and completion of treatment. It will also explore management strategies for women with non-16/18 hrHPV based on extended genotyping and HPV viral load compared to standard of care approaches using visual inspection with acetic acid (VIA).

Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.

The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel promotes regression of CIN1/CIN2 and facilitates HPV clearance in women aged 30-50 years diagnosed with CIN1 or CIN2 and HPV. In addition, the study will assess patient satisfaction, treatment compliance and characterize the vaginal microbiome. The primary outcomes therefore is: * the regression of the cervical dysplasia from baseline to the follow-up (6 months), which will be assessed through either liquid-based cytology and/or histopathology (biopsy). * HPV clearance from baseline to follow-up (6 months) In this randomized controlled study, eligible participants will be randomized 1:1 into two groups: 1. Intervention group: Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle). 2. Control group; Women (n=35) will follow the conventional "wait and see" approach.

Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection

Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer. However, a large population was left unvaccinated, specifically for those aged ones. In clinic, patients harboring high-risk HPV is quite prevalent in China or other developing nations. Removing the virus and prevention of malignant transformation is required. Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilized in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with HR-HPV in cervical area. So the purpose of the study is to evaluate the effective of local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months. Appropriate control arms were designed for different conditions.

Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs

The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR (high-risk human papillomavirus) positivity and cervical lesions. Additionally, in collaboration with the Bioptic Laboratory, the study will analyze the integration of HPV HR testing into screening programs for women aged 35, 45, and 55, with a focus on optimizing management strategies for HPV HR-positive women. Research Objectives: * Evaluate spontaneous regression/progression over two years based on HPV HR genotyping (three groups - according to Alinity: high, intermediate, and low risk). * Assess spontaneous regression/progression over two years based on HPV HR genotyping and viral load in HPV-vaccinated vs. non-vaccinated patients. * Evaluate spontaneous regression/progression over two years based on methylation results. * Assess spontaneous regression/progression over two years based on CinTec plus results.

Correlation Between Selenium Levels in Human Tissues and HPV-related Cervical Lesions and Outcomes

This study investigates the relationship between selenium levels in human tissues and the persistence of HPV (human papillomavirus) infection, particularly focusing on cervical-related lesions. The main objectives are to explore the correlation between selenium levels in different body samples (hair, nails, urine, and blood) and to evaluate selenium's potential protective effects against HPV persistence and its progression to cervical lesions. Key goals of the study include: Determining whether non-invasive monitoring (e.g., hair, nails, urine) can accurately reflect blood selenium levels. Understanding how selenium levels fluctuate in women with persistent HPV infection, and whether selenium supplementation can reduce the risk of HPV-related cervical disease progression. Exploring selenium's role in enhancing immune function, especially in older adults, to help clear HPV infection. By recruiting volunteers for selenium level testing and tracking HPV-positive women over time, this research aims to provide evidence on the effectiveness of selenium in preventing cervical cancer progression and potentially clearing HPV infections.