Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Squamous Intraepithelial Lesions of the Cervix

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Cervical Dysplasia

Precancerous Conditions

Cervical Intraepithelial Neoplasia

DNA methylation for the cervical cytology

DNA methylation

High-risk HPV testing for the cervical cytology

High-risk HPV

Thin prep liquid-based cytology test for the cervical cytology

Lei Li

Lei Li, MD

Lei Li, M.D.

The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study.

This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.

The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.

Uterine cervical cytology collected during the clinical settings for the testing of DNA methylation, TCT and high-risk HPV

DNA Methylation for Screening Uterine Cervical Lesions

DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study

Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL)

Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

Correlation coefficient of DNA methylation with high-risk HPV and TCT results

Professor

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Anti-Infective Agents

All Drugs and Chemicals

Cidofovir

Antiviral Agents

Enzyme Inhibitors

Women receiving an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).

Catherine Vanpachterbeke, MD

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.

A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.

A Prolongation of Phase II Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions

A gynecological examination will be done, including colposcopy. Cervical sampling for virology will be taken and sent to Riatol laboratory. A biopsy will be taken in presence of colposcopic cervical squamous intraepithelial neoplasia (CIN2-3) lesions, or in case of colposcopic doubt lesions, or in case of persistence (after 6 months) of colposcopic CIN1 lesion or if the last cytology was a high grade squamous intraepithelial lesion (HSIL) cytology, or if the last cytology suspected glandular lesions, or if the two last cervical smears were low-grade intraepithelial lesion (LSIL) cytologies with presence of high risk human papillomavirus (HPV).The biopsy fixation, HE (eosin-hematoxylin) staining and P16 + Ki67 staining will be done according to a validated procedure. Biopsy slides will be send to the central lab for immunological and histological reading (three pathologic experts).

Cervical sampling for virology will be taken and send to Riatol laboratory.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DNA Methylation for Screening Uterine Cervical Lesions	NCT03960879	DNA Methylation Uterine Cervica... High Grade Squa... Low Grade Squam...	DNA methylation High-risk HPV TCT	18 Years -	Peking Union Medical College Hospital
DNA Methylation for Screening Uterine Cervical Lesions	NCT03960879	DNA Methylation Uterine Cervica... High Grade Squa... Low Grade Squam...	DNA methylation High-risk HPV TCT	18 Years -	Peking Union Medical College Hospital
A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.	NCT02976987	High Grade Cerv...	Cidofovir	18 Years - 50 Years	Brugmann University Hospital
A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.	NCT02976987	High Grade Cerv...	Cidofovir	18 Years - 50 Years	Brugmann University Hospital

Spots Global Cancer Trial Database for high grade squamous intraepithelial lesions