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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cidofovir | Experimental | Women receiving an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cidofovir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 months after initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| HPV viral load | Cervical sampling for virology will be taken and send to Riatol laboratory. | 24 months after initial treatment |
| HPV genotype | Cervical sampling for virology will be taken and send to Riatol laboratory. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Vanpachterbeke, MD | CHU Brugmann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brugmann Hospital | Brussels | 1020 | Belgium |
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| 24 months after initial treatment |
| ID | Term |
|---|---|
| D000081483 | Squamous Intraepithelial Lesions |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077404 | Cidofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003596 | Cytosine |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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