A Phase 2 interventional study of Cidofovir in High Grade Cervical Epithelial Neoplasia (CIN2+), sponsored by Brugmann University Hospital. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-11-30.
Sponsored by Brugmann University Hospital · Phase 2, Interventional, and Treatment
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
49 studies on the registry are indexed under Squamous Intraepithelial Lesions of the Cervix; 13 are open to participants now.
This study's enrollment of 36 is below the median of 81 across 33 interventional studies indexed under Squamous Intraepithelial Lesions of the Cervix.
Browse Squamous Intraepithelial Lesions of the Cervix studies →Brugmann University Hospital is the lead sponsor of 116 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women receiving an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).
Drug: Cidofovir
change in biopsy conclusions (treatment success or not)
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).
Time frame: 24 months after initial treatment
HPV viral load
Cervical sampling for virology will be taken and send to Riatol laboratory.
Time frame: 24 months after initial treatment
HPV genotype
Cervical sampling for virology will be taken and send to Riatol laboratory.
Time frame: 24 months after initial treatment
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Squamous Intraepithelial Lesions of the Cervix→
Brugmann University Hospital