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Human Papillomavirus clinical trials

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NCT ID: NCT05931354 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Longitudinal HPV Pap in CIN and VAIN

LHPCV
Start date: July 1, 2017
Phase:
Study type: Observational

This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+. The study will include three arms to complete the follow-up data for the previous cohort constructed, and prospectively recruit new subjects with the appropriate inclusion/excluding criteria in order to increase sample size of this study.

NCT ID: NCT05672927 Recruiting - HPV Infection Clinical Trials

Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)

Start date: January 18, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.

NCT ID: NCT05413811 Recruiting - Cervical Cancer Clinical Trials

Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV

ACT2
Start date: March 22, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.

NCT ID: NCT05365048 Recruiting - Clinical trials for Human Papillomavirus

Provider Recommendation and HPV Vaccination

HPVV
Start date: March 21, 2022
Phase: N/A
Study type: Interventional

In the United State, there are millions of US teens who are not vaccinated against the human papillomavirus (HPV) putting them at risk of getting HPV-related cancers. Although there are clinical guidelines recommending the HPV vaccine and interventions encouraging parents to vaccinate their children to prevent HPV-related cancers, the vaccination rate for teens remains low according to a 2018 national survey. Survey data shows that HPV vaccine complete series coverage for teens aged 13-15 years was 50%, far below the 80% target of Healthy People 2020. Receiving a strong provider recommendation is the most powerful strategy for improving HPV vaccine rates. Yet, little is known about how to include provider recommendations and other important factors into an intervention to improve the HPV vaccination rates. Studies show there are provider, patient and system-level barriers in the initiation and completion of HPV vaccine series among 9-12 years old children. Barriers to the HPV vaccine also differ across demographic subgroups, communities, and clinics. Interventions that address only one component are not responsive to site barriers and as effective as one that addresses multiple components and site-specific barriers. This study uses a 3-arm cluster randomized controlled trial (RCT) to compare three implementation strategies to improve provider recommendations on the HPV vaccine. Two of the implementation strategies (local-tailored and prescribed strategy) utilize a multilevel approach. The three implementation strategies of interest are (1) a "local-tailored" implementation strategy, co-designed with local care teams to address local barriers and contexts (2) A "prescribed" strategy, most commonly used by health systems, that involves pre-specified interventions addressing pre-selected vaccination barriers and (3) usual standard of care where there are no research-led activities. We will use surveys, interviews, and electronic health records to evaluate the three implementation strategies and their impact on improving HPV vaccination rates. The study surveys and interviews will include pediatric providers, nurses, administrators, staff members, and parents of HPV vaccine-eligible children (9-12 years old). Successful implementation will be defined as improvement in HPV vaccination rates (primary outcome), strengthening provider recommendation (secondary outcome), and the cost-effectiveness of the implementation strategy.

NCT ID: NCT05026138 Recruiting - Clinical trials for Human Papillomavirus

Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)

Start date: November 17, 2021
Phase:
Study type: Observational

Background: Most symptoms of human papillomaviruses (HPV) infection, do not cause serious health problems, but some do. As HPV can cause uncontrolled growth of infected cells, some people can develop benign skin lesions, larger warts, genital lesions, tumors or cysts that do not respond to treatment. Researchers want to learn why. Objective: To better understand why some people are more likely than others to get sick from HPV infection, and why medicine or surgery is not always effective. Eligibility: People aged 3 years and older who have had multiple outbreaks of HPV-related warts and/or lesions that do not respond to treatment. Healthy relatives are also needed. Design: Participants will be screened with a medical history, physical exam, and blood tests. Participants may have study visits as an outpatient or an inpatient (admitted overnight to the NIH hospital) and be followed over several years by our doctors and researchers at the NIH. Participants may have a cervical and/or anal Pap test. They may give samples of semen, cervicovaginal secretions, urine, saliva, or stool. Small pieces of skin, the inside of the cheek, and/or the gums may be collected with a punch or scrape biopsy to understand how HPV affect the growth of cells. Mucus and skin may be collected by rubbing the area with a cotton swab. Collection areas may include the inside the mouth, nostrils, skin, genitals, and/or in or around the anus. Biopsies may be collected. If participants need to have a biopsy as part of medical care, then we may ask if extra samples can be collected for research. Biopsies we may collect are bone marrow, lymph node, genitals, or in or around the anus. Participants may have leukapheresis. Blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned through a needle in their other arm. Samples may be used for genetic tests and/or to make special cells called induced pluripotent stem cells. Participants may have follow-up visits once a year for 10 years. Benefits: We are not testing new HPV treatments in this study and you might not benefit from participating. However, we may learn new information about your condition that we will share with you and your doctor. We may make recommendations for your medical care based on current accepted treatment. What we learn from you and other participants in this study might help other people. We hope we can use this information to develop new treatments and therapies in the future....

NCT ID: NCT04901351 Recruiting - Clinical trials for Human Papillomavirus

Multi-site HPV Screening by High-throughput Sequencing in Patients With Chronic HPV-HR Infection Followed by Gynecology

DEP-HPV
Start date: June 21, 2022
Phase: N/A
Study type: Interventional

The main risk of developing cervical cancer is the persistence of an High risk human papillomavirus (HPV-HR) infection, the mechanisms of which are still not understood. These chronically infected patients could develop multi-site lesions. The main objective is to assess the feasibility of setting up a personalized screening in patients at high risk of cervical cancer (chronically infected with HPV), by evaluating documenting the acceptability of these patients to be sampled from the ENT sphere and anal spheres for HPV analysis with next-generation sequencing.

NCT ID: NCT04708470 Recruiting - Cervical Cancer Clinical Trials

A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers

Start date: October 5, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers. Objective: To find a safe dose of entinostat in combination with NHS-IL12 and bintrafusp alfa and to see if this treatment will cause tumors to shrink. Eligibility: Adults ages 18 and older who have cervical, oropharyngeal, anal, vulvar, vaginal, penile, squamous cell rectal, or another cancer that may be associated with HPV infection or microsatellite stable small bowel or colorectal cancer. Design: Participants will be screened with a medical history and physical exam. Their ability to do daily activities will be assessed. They may have imaging scans of the brain and/or chest, abdomen, and pelvis. They may have nuclear bone scans. They will have an electrocardiogram to test heart function. They will have blood and urine tests. They may have a tumor biopsy. Participants with skin lesions may have them photographed. Some screening tests will be repeated during the study. Treatment will be done in 28-day cycles. Participants will get bintrafusp alfa through an intravenous catheter every 2 weeks. They will get NHS-IL12 as an injection under the skin every 4 weeks. They will take entinostat by mouth once a week. They will complete a medicine diary. Participants will get treatment for 2 years. They will have 1-2 follow-up visits in the 30 days after treatment ends. Then they will be contacted every 6 months to check on their health.

NCT ID: NCT04371887 Recruiting - Cervical Cancer Clinical Trials

Comparing Strategies for Implementing Primary HPV Screening

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Cervical cancer screening is an important component of women's health care. Most adult women are familiar with the conventional screening modality, Pap test, which has successfully reduced the burden of cervical cancer in industrialized countries. However, Pap test has limited accuracy and can miss a progressing disease. Advancement in knowledge and technology has led to changes in national recommendations to focus on the testing of high-risk human papillomavirus (HPV) infection, the cause of cervical cancer. Screening with primary HPV testing detects more diseases compared with Pap test alone or co-testing, and requires less number of tests. However, despite the advantages of primary HPV screening over conventional approaches, the switch to primary HPV screening is limited in the United States. The scientific literature reports barriers at both the provider and women level, which include lack of knowledge, resistance, and attachment to Pap test. We currently have insufficient guidance on how to select and deploy implementation strategies most likely to facilitate use of newly recommended cancer screening modality. This project seeks to generate evidence regarding effective strategies to achieve successful implementation of the primary HPV testing for routine cervical cancer screening in a large community-based health care system. A successful implementation will be defined by uptake of the primary HPV screening, adequate knowledge of the HPV test for both patients and providers, and patient/provider satisfaction during the transition. This project is important to most adult women, as a timely adoption of the best evidence-based cancer screening approach means better patient outcomes. Further, the proposed project will not only inform about cervical cancer screening, but other clinical conditions when a physician practice change is recommended by professional societies and/or national guideline body. By engaging patients, providers and other professional stakeholders in this project, we ensure that successful project outcomes are those most important for women and their doctors. Further, the stakeholder partners will help ensure generalizability of our findings to other health care systems, design strategies that maximize completeness in data collection, and lead the dissemination effort for wide application of the knowledge to be gained in this project.

NCT ID: NCT03742869 Recruiting - Clinical trials for Human Papillomavirus

HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma

Start date: November 10, 2018
Phase:
Study type: Observational

This study aims to analyze the multi-omics results between uterine cervical adenocarcinoma patients with and without human papillomavirus (HPV) infections. The multi-omics profiles include genome wide association study (GWAS), whole exome sequencing, analysis of transcriptomics and metabolomics. The HPV integration status is interpreted by GWAS. A comprehensive multi-omics will reveal the role of HPV integration in the molecular mechanism of tumorigenesis and prognosis of uterine cervical adenocarcinoma.

NCT ID: NCT02126189 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study

Start date: November 2013
Phase: N/A
Study type: Observational

This study is designed to refine the aetiological causes of cancers of the head and neck and investigate the ways in which human papillomavirus and life-style factors cause head and neck cancers. This study will determine if these factors affect the treatment of cancer. All patients attending the Head and Neck Clinic at the Princess Alexandra Hospital is invited to complete a risk factor questionnaire and give consent for their clinical data and tissue samples to be available for future research activities. The risk factor questionnaire is based on existing validated instruments developed by the QIMR Berghofer Medical Research Institute Cancer Control Group, and will collect standardised information relating to demographics and causal factors (tobacco and alcohol intake), risk modifiers (dentition, asprin and non-steroidal anti-inflammatory drugs (NSAIDS), height, weight, physical activity, diet quality etc) and behaviours (oral sex etc)