Active clinical trials for "Squamous Intraepithelial Lesions of the Cervix"

This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection

Low-grade squamous intraepithelial lesions (LSIL) are premalignant changes on the cervix that can lead to malignant changes, i. e. cervical cancer. Alpha-lipoic acid is a fatty acid that is naturally found in food, and due to its proven antioxidant and anti-inflammatory effects, it is increasingly used as a dietary supplement, most often to alleviate the symptoms of various neuropathic conditions. The purpose of this study was to demonstrate efficiency, safety, and clinical benefit of alpha lipoic acid (ALA) in inducing regression of LSIL. The hypothesis is based on the proven role of oxidative stress and inflammation in formation of LSIL and anti-inflammatory and antioxidative efficiency of ALA. The study was designed as randomized, double-blind, two-arm, placebo-control trial recruiting 100 female patients with diagnosed LSIL. Patients received 600 mg/day of ALA or placebo for 3 months. Progression/regression of LSIL has been defined as primary outcome of the study; inflammation markers and oxidative stress parameters have been defined as secondary outcomes of the study.

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

The purpose of this study is to test the safety and efficacy of an investigational immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar high-grade squamous intraepithelial lesion (HSIL) [vulval intraepithelial neoplasia 2 or 3 (VIN 2 or VIN 3)] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is being assessed as an alternative to surgery with the potential to clear the underlying HPV infection. For more information visit our study website at: www.VINresearchstudy.com

This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of VGX-3100.

The infections of high grade induced by the human papilloma viruses cause precancerous lesions of the cervical epithelium. The progression of these lesions can lead to the onset of cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3' (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to complications such as infertility or a risk of preterm birth, hence the need to move towards a non-surgical alternative therapy. The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3). This clinical trial is a prolongation of the colvir trial, in order to assess the long term histological and virological evolution (24 months) of 3 g of 2% (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade intraepithelial neoplasia after complete response, partial response or response failure at the end of the Colvir study. assess the long term (24 months) rate of recurrence of histological lesions of the Colvir patients after conisation, in both placebo and treatment groups.

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

Anal cancer can be prevented through detection and treatment of a recognised precancerous lesion, known as anal intra-epithelial neoplasia (AIN), specifically the anal high-grade squamous intra-epithelial lesion (aHSIL) subtype. Assessment of changes in disease burden is an important feature in the clinical evaluation of a treatment. Existing trials in aHSIL have predominantly used disease response outcomes based on histological and cytological changes to measure the effects of treatment. Several limitations to this approach have been identified. Lesion characteristics such as lesion size and number represent potential indicators of disease response to treatment and might overcome some of the limitations. We aim to develop a disease measurement instrument capable of describing disease burden such that it can be used to evaluate disease response to treatment in addition to histological and cytological based measurements further strengthening the quality of disease response outcomes. The disease measurement instrument will be developed over 4 stages: A meeting of AIN experts to determine a longlist of lesion measurement items capable of capturing disease burden; A series of disease assessments will be undertaken in participants known to have aHSIL to assess disease burden using the measurement items identified in stage 1; Data analysis to determine the best performing measurement items and comprise a disease measurement instrument; Pilot-testing of the proposed disease measurement instrument. Two trained disease assessors (experienced clinicians familiar with the assessment of anal intraepithelial lesions) will assess disease burden per participant. Disease burden will also be captured photographically. We will undertake disease assessments on 20-30 participants. By analysing the results of the clinician assessments and digital analysis of the photographic representation of disease burden, we will be able to determine the most acceptable, feasible, reliable and reproducible ways of measuring disease burden and use these to inform a disease measurement instrument.

This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.

HPV-303 is a prospective, randomized, double-blind, placebo-controlled phase 3 study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) of the cervix, associated with HPV-16 and/or HPV-18.