High Grade Cervical Epithelial Neoplasia (CIN2+) Clinical Trial
Official title:
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
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - Women who participated in the COLVIR study and received complete treatment Exclusion Criteria: - Women from the Colvir study who received incomplete treatment |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Brugmann Hospital | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Brugmann University Hospital |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | HPV viral load | Cervical sampling for virology will be taken and send to Riatol laboratory. | 24 months after initial treatment | No |
| Secondary | HPV genotype | Cervical sampling for virology will be taken and send to Riatol laboratory. | 24 months after initial treatment | No |