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Papillomavirus Infections clinical trials

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NCT ID: NCT04206813 Recruiting - HPV Infection Clinical Trials

An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen

Start date: December 1, 2020
Phase: Phase 4
Study type: Interventional

The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.

NCT ID: NCT04171505 Recruiting - HPV Infection Clinical Trials

Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.

VENUS
Start date: November 4, 2019
Phase:
Study type: Observational

A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-related disease will be evaluated. For this purpose, the percentage of cervical lesion recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015. It will be an essential requirement that the patient provide a vaccination card from their health center where there is proof of their immunization status and date of administration. Inclusion criteria: - Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically. - Women who sign informed consent. - Patients with negative results in the first post-surgery control. - Patients who have received HPV vaccination and provide vaccination card. Exclusion criteria: - Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study. - Patients treated by an indication other than HSIL/CIN. - Patients under immunosuppression conditions.

NCT ID: NCT04124198 Recruiting - Quality of Life Clinical Trials

Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma

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

Oropharyngeal squamous cell carcinoma (OPSCC) is now the most frequently diagnosed head and neck cancer in Denmark which is mainly due to the increase of Human Papillomavirus (HPV). Patients with HPV-positive OPSCC have a significantly higher survival rate compared to HPV-negative OPSCC. The traditional primary treatment modality in Denmark is Intensity Modulated Radiation Therapy (IMRT), and in advanced stages in combination with chemotherapy. Since 2009, Transoral Robotic Surgery (TORS) has enabled surgeons to perform minimally invasive surgery as an alternative to standard radiotherapy treatment which is considered the primary treatment for OPSCC in many countries. There is a lack of randomised trials comparing long-term functional outcomes after TORS or IMRT. Current data are mostly derived from retrospective studies with selection bias. However, several small retrospective studies have shown promising results when comparing the two treatment modalities in favour of TORS with regards to treatment related swallowing function and quality of life (QoL) without compromising survival outcomes. This study aims to evaluate the early and long-term functional outcomes following two treatment arms 1) TORS combined with neck dissection and 2) IMRT±concurrent chemotherapy with a special focus on swallowing-related QoL.

NCT ID: NCT04098744 Recruiting - HPV Infection Clinical Trials

Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)

ART-CIN_IIB
Start date: September 9, 2020
Phase: Phase 2
Study type: Interventional

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).

NCT ID: NCT04057924 Recruiting - Cervical Cancer Clinical Trials

Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN

SUIVICIN
Start date: August 23, 2019
Phase:
Study type: Observational

This study proposes to describe and evaluate the rate of spontaneous regression of CIN2 at 2 year of follow up in women between 18 and 39 year old. This follow-up is proposed as an alternative to the treatment of reference (conization) with a possible extension to 4 years

NCT ID: NCT03961178 Recruiting - Pregnancy Clinical Trials

A Cohort Study for the Following up of Conization

Start date: June 3, 2019
Phase:
Study type: Observational

This study is to investigate the oncologic and obstetric outcomes in patients with conization for uterine cervical lesions from January 1, 2000 to January 1, 2019 in Peking Union Medical College Hospital. The primary objectives consist of following: 1. The cumulative incidences of precancerous lesions and cancers of lower genital tract in patients who accepted conization for high grade intraepithelial neoplasia (HSIL), carcinoma in situ and stage IA1 cancer (FIGO 2009) 2. The cumulative pregnancy rates in patients sparing the fertility The secondary objectives consist of following: 1. The effects of surgical protocols (modified Sturmdorf method and "8" figure suture) and energy equipment (cold knife and monopolar electrical cautery) on the oncologic and obstetric outcomes, and on the histological components. 2. A full description of histological components of the conization specimens 3. The cytological and virus outcomes after conization, based on the thin prep liquid-based cytology test (TCT) and high-risk human papillomavirus (HPV) testing

NCT ID: NCT03895866 Recruiting - Clinical trials for HPV-Related Squamous Cell Carcinoma

Persistent Cervical HPV Infection With Clearance and Vaginal Microbiota

Start date: April 11, 2019
Phase:
Study type: Observational [Patient Registry]

Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the persistence infection and clearance of HPV infection.

NCT ID: NCT03789513 Recruiting - HIV Infections Clinical Trials

Evaluation of Triage Options After HPV Testing for Cervical Cancer Screening Among HIV-infected Women

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

Cervical cancer is the most common cause of cancer and a leading cause of death among HIV-infected women living in resource-limited settings. Although screening for premalignant lesions is an effective way of reducing cervical cancer incidence, its uptake in low-resource settings to date is low. The use of HPV testing for primary screening is currently recommended by many guidelines - including the WHO guidelines for cervical cancer screening in resource-limited settings - because of its greater sensitivity and ease of use compared to other options. However, these WHO guidelines have both highlighted the need to conduct more research on appropriate HPV-based algorithms among HIV-infected women, as immunodeficiency may affect the screening performance. Indeed, HPV infections in HIV-infected women are very common, so there is a need for additional triage to identify women most at risk and there remains considerable uncertainty on the optimal option for such triage. Most of the evidence available comes from HIV-negative populations living in high-resource settings and is not necessarily relevant for low-resource contexts where the epidemiological background is different, women access late to screening and may not have follow up visits, where financial constraints are important and health service resources limited. Hence, the proposed project aims to provide evidence on the effectiveness and feasibility of HPV-based screening algorithms among HIV-infected women in low-resource settings. This multicenter cross-sectional study will include 3,000 HIV-infected women (30-49 years old) receiving HAART and followed in Abidjan (Ivory Coast), Bobo-Dioulasso (Burkina Faso) and Phnom Penh (Cambodia). After self-collection of cervico-vaginal samples, each participant will have an HPV test with partial genotyping primary using the Xpert HPV assay, a real-time PCR assay that provides the possibility of identifying 14 HR-HPV types within one hour. The Xpert HPV test has been chosen because of the wide availability of the Genexpert platform in HIV care centers from resource-limited settings. Furthermore, it can specifically detect HPV-16, 18 and 45, the most carcinogenic HPV types in both HIV-negative and HIV-positive women, separately from other high-risk HPV types. VIA will be another triage option either alone or combined to HPV DNA genotyping. In addition, participants treated for cervical lesion will be followed over 12 months to assess the risk of post-treatment lesions (CIN2+/HSIL) and to identify associated risk-factors.

NCT ID: NCT03577925 Recruiting - Clinical trials for the High-Risk HPV Infection

The Standard Management of HPV Infection

Start date: October 1, 2016
Phase:
Study type: Observational

High-risk human papillomavirus (HR-HPV) infection is a necessary condition in the occurence and development of cervical squamous intraepithelial lesion (SIL) and cervical cancer. There are cases that high-grade SIL (HSIL) and stage IA1 cervical squamous cancer remain or reoccur, or even become more severe after conization. The infection situation of HR-HPV, which plays an important role in the prognosis of cervical lesion, should be consulted in the management and follw-up after conization. It is worthwhile making further study in the specific practical significance of the HR-HPV in the prognosis of cervical lesion, as well as the high-risk factors that influence the prognosis of HR-HPV.

NCT ID: NCT03548740 Recruiting - Clinical trials for Papillomavirus Infections

Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection

Start date: September 1, 2018
Phase:
Study type: Observational [Patient Registry]

Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.