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Cervical Intraepithelial Neoplasia clinical trials

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NCT ID: NCT04969445 Recruiting - Cervical Cancer Clinical Trials

The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

Start date: March 30, 2021
Phase:
Study type: Observational

The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

NCT ID: NCT04788849 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia Grade 2/3

Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples

Ext-VALHUDES
Start date: March 8, 2021
Phase:
Study type: Observational

The "Extended VALHUDES" study is a Clinical Performance / Diagnostic Test Accuracy Study that aims to extend validation, achieved as part of the "Belgian VALHUDES", of HPV testing using BD Onclarity on samples collected using Copan's devices for dry self-sampling of vaginal material and for first-void urine: FLOQSwab® 5E089N and UriSpongeā„¢.

NCT ID: NCT04783805 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Start date: March 3, 2021
Phase:
Study type: Observational

Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (<30 years), but evidence is insufficient on whether it is also advisable for older women. This study will be conducted to analyze spontaneous HSIL regression rates in women of reproductive age and establish whether conservative HSIL management could be safely recommended to women of childbearing potential, irrespective of age. This is a single-center prospective observational study that will include consecutive women of reproductive age, referred to a tertiary hospital due to HSIL between March 2021 and December 2025, who prefer conservative management rather than immediate cervical conization. All patients will be followed-up regularly with colposcopy, cytology, human papillomavirus (HPV) testing and biopsies. In case their lesions progress or HSIL persists after 24 months of follow-up, conization will be indicated. Rates of spontaneous regression or resolution, as well as progression rates, will be assessed. Furthermore, the association between potential predictive factors and HSIL resolution will be analyzed.

NCT ID: NCT04783649 Recruiting - Cervical Cancer Clinical Trials

Clinical Validation of Cervical Cancer Screening Methods

Start date: July 13, 2020
Phase:
Study type: Observational

This single-institution cross-sectional non-inferiority validation study evaluates alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests.

NCT ID: NCT04753073 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia III

Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma

ZGynO_CINIII
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions. - The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision. - Another aim of this study is to investigate cellular / molecular effects of NIPP following the in-vivo treatment of the cervix using molecular biological methods. For this purpose, tissue treated with plasma is taken after defined periods of time by mini biopsy and examined using molecular biological, histological and microscopic methods.

NCT ID: NCT04712851 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

Start date: June 30, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of pembrolizumab on cervical intraepithelial neoplasia. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT04650711 Recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Start date: November 26, 2020
Phase: Phase 2
Study type: Interventional

Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

NCT ID: NCT04646954 Recruiting - Cervical Cancer Clinical Trials

DNA Methylation Testing for the Screening of Uterine Cervical Lesion

Start date: November 26, 2020
Phase: Phase 3
Study type: Interventional

In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

NCT ID: NCT04278326 Recruiting - Cervical Cancer Clinical Trials

Primary Organoid Models and Combined Nucleic Acids Therapeutics for Anti-HPV Treatments

ORGANOIDES
Start date: March 6, 2020
Phase: N/A
Study type: Interventional

Human papilloma virus (HPV) is responsible of the most common sexually transmitted infection. It can cause severe cancer lesions, of the cervix, vulva, vagina, penis and oropharynx. The International Agency for Cancer Research of World Health Organization (WHO) classified a dozen of HPV related high-risk cancer types, and recognized cervical cancer as the most common HPV-related disease. HPV 16 and 18 are responsible for 70% of cervical cancers. Due to the few symptoms of cervical cancer, women are often diagnosed with advanced state. Current treatments imply cervical conisation or hysterectomy, with or without lymphadenectomy and or radiotherapy, or chemotherapy. However, few pharmacological options are available against oncogenic papilloma viruses and thus against recurrences The aim of this project is to develop relevant organoids models from patient biopsies that will be used to identify biomarkers and evaluate in a closest preclinical setting novel nucleic acids based therapeutic strategy for HPV-cervical-vaginal dysplasia and cancers.

NCT ID: NCT04249856 Recruiting - Cervical Cancer Clinical Trials

Colposcopy and Dynamic Spectral Imaging (DSI)

Start date: February 1, 2017
Phase:
Study type: Observational

This study evaluates the Dynamic Spectral Imaging (DSI) Colposcope (DySIS) in it's ability to diagnose cervical dysplasia. Half of participants with be examined by the DySIS colposcope, there the other half will be examined by standard colposcopy.