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HPV Infection clinical trials

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NCT ID: NCT05911750 Recruiting - HPV Infection Clinical Trials

Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

PAPIMALE
Start date: February 12, 2023
Phase:
Study type: Observational

The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.

NCT ID: NCT05883111 Recruiting - HPV Infection Clinical Trials

HPV Self-testing in Transgender Individuals

Self-TI
Start date: February 29, 2024
Phase: N/A
Study type: Interventional

Human papillomavirus (HPV) is a common virus that spreads through skin-to-skin contact. Some HPV types can cause changes in cells that lead to cancer and are known as 'high-risk' HPV (hrHPV). hrHPV is linked to cancers of the cervix (opening of the womb), throat, and anus (exit of the bowel). It is not known if transgender people (individuals whose gender identity does not align with their sex assigned at birth) are at increased risk of hrHPV or cancers caused by hrHPV compared to cisgender people (individuals whose gender identity does align with their birth sex). There is also little knowledge about HPV in the vagina for transgender women who have surgery to make one. Transgender men may be at higher risk of cervical cancer than cisgender women because they are less likely to go for screening. This can be because of physical discomfort and emotional distress during screening when a swab is taken directly from the cervix. The investigators seek to examine how common hrHPV is in transgender people in different parts of the body. In the study, participants will take swabs from the vagina and anus, a urine sample, and use mouthwash. Transgender men will also have an extra swab taken by a clinician as part of routine cervical screening. This is to see if the swab from the vagina is as good as the one from the cervix for finding cells that might lead to cancer. Participants will also take an online survey to measure the acceptability of self-sampling compared to clinician sampling. This research can inform HPV prevalence and decision-making about HPV screening among transgender people.

NCT ID: NCT05829629 Recruiting - HPV Infection Clinical Trials

Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women

Start date: September 12, 2023
Phase: Phase 1
Study type: Interventional

BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).

NCT ID: NCT05808816 Recruiting - HPV Infection Clinical Trials

"Lactobacillus Crispatus M247, LSIL and Microbiota"

Start date: June 16, 2021
Phase: Phase 4
Study type: Interventional

Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m

NCT ID: NCT05745597 Recruiting - HPV Infection Clinical Trials

Prognostic Study of HPV Virus Integration in Women With HSIL

Start date: January 1, 2023
Phase:
Study type: Observational

Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.

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: NCT05587738 Recruiting - Cancer Clinical Trials

Human Papillomavirus in Young People Epidemiological Research 4

HYPER4
Start date: January 1, 2023
Phase:
Study type: Observational

Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013; with a 2-year catch-up for boys aged up to 15 years. The goal of the HYPER4 study is to determine the prevalence of anal, genital and oral HPV among 500 young gay and bisexual men aged 21-25 years who were eligible for the school-based gender-neutral quadrivalent vaccination program. Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.

NCT ID: NCT05587725 Recruiting - Cancer Clinical Trials

Human Papillomavirus in Young People Epidemiological Research 3

HYPER3
Start date: January 1, 2023
Phase:
Study type: Observational

Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013Íž with a 2-year catch-up for boys aged up to 15 years. In 2018, the 9-valent vaccine (covering genotypes 6/11/16/18/31/33/45/52/58) replaced the 4-valent vaccine in the national program. The goal of the HYPER3 study is to determine the prevalence of anal, genital and oral HPV among 200 young gay and bisexual men aged 16-20 years who were eligible for the school-based 9-valent vaccination. Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.

NCT ID: NCT05570331 Recruiting - Cervical Cancer Clinical Trials

Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women

Start date: January 1, 2022
Phase:
Study type: Observational

The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.

NCT ID: NCT05509413 Recruiting - HPV Infection Clinical Trials

DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections

HPV-VG1
Start date: November 8, 2022
Phase: N/A
Study type: Interventional

Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide and in most cases are causally associated with the development of cervical cancer, one of the most common cancers in women and one of the leading causes of death in women worldwide. Precancerous lesions (dysplasias) or the presence of a high-risk HPV subtype are detected by a screening smear test performed by a gynecologist. If precancerous lesions are detected, conization (= surgical removal of a cone of tissue from the cervix) is the method of choice for removing the diseased tissue. However, if the degree of dysplasia is correspondingly low or the smear is unclear, then the guideline-compliant non-surgical treatment provides for a wait-and-see approach with PAP and HPV smear control after 6-8 months. This "wait-and-see" approach can be complemented by local therapy with an immunostimulant. For this purpose, DEFLAGYN® (a vaginal gel containing silica and citric acid) and Aldara® (imiquimod, a Toll-Like Re-ceptor 7 antagonist) are available. However, while the latter is not approved for the treatment of cervical dysplasia or HPV infection, DEFLAGYN® has CE marking and approval as a medical device for treatment in a number of indications, such as unclear cervical smears, HPV-induced cervical lesions, p16/Ki-67-positive cervical lesions or cervical erosions. However, available studies on the efficacy of DEFLAGYN are limited. For example, there is only one prospective randomized trial (Major et al, 2021, Arch. Gynecol. Obstet. 303:501-511), which included 216 women with histologically confirmed CIN 1/2. A 3-month intravaginal application of DEFLAGYN® resulted in regression of CIN 1/2 in 72% versus 25% in the control arm (no intervention). Side effects of therapy with DEFLAGYN® were not observed in this study. Due to the frequency of CIN and HPV infections in the female population and due to the high medical relevance of a conservative method of treating this disease, further methodologically high-quality studies on the efficacy of DEFLAGYN® should be performed.