Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2
Conditions
Brief summary
Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2. The device system is to be used only in accordance with the approved Investigational Plan on subjects, who have given written informed consent. High remission and regression rates are expected after a single topical treatment with 85% TCA. After a single topical treatment with 85% TCA for CIN 1-2 (Expected 70% or higher; null hypothesis: not higher than 55%). Regression is defined as improvement from high grade lesion (CIN 2) at baseline to low grade lesion (CIN 1) after TCA treatment. Regression from CIN 1 normal squamous epithelium after the TCA treatment is equal to remission and will be counted as a remission in combined analysis. Remission is defined as complete histologic remission of CIN back to normal squamous epithelium after the TCA treatment, i.e., no cervical dysplasia is detectable by histology or cytology after the TCA treatment. Type-specific HPV Clearance is defined as disappearance of the HPV type detected at screening.
Detailed description
Visit and assessment Schedule: Visit1 Screening: * Informed Consent, * Inclusion/Exclusion Criteria, * Medical History, * Gynecological Examination * Cytology * HPV Test * Colposcopy * Biopsy * VAS (Visual analog scale) * Pregnancy test Visit 2 Treatment Day with TCA 85%: * Colposcopy * TCA Treatment * VAS * Pregnancy test Visit 3, Control 1, Week 10-14: * Cytology * HPV Test * Colposcopy * Biopsy * 4-quadrant biopsy * ECC * Adverse event monitoring If there is no sign of CIN during the colposcopic examination 10-14 weeks a 4-quadrant biopsy and a ECC are performed Visit 4, Control 2, Week 22-26: * Cytology * HPV Test * Colposcopy * Biopsy * 4-quadrant biopsy * ECC * Adverse event monitoring * Pregnancy test If there is no sign of CIN during the colposcopic examination 22-26 weeks after the TCA treatment, a 4-quadrant biopsy and a ECC are performed. Visit 5, EOS , Week 24-30: \- Results Discussion
Interventions
DEVICETrichloroacetic acid 85% (TCA)
Purpose and scope of Medical Device: Treatment and relief of a disease. Application to cervical intraepithelial neoplasia with a cotton swab.TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.
Sponsors
Medical University of Vienna
Krankenhaus Barmherzige Schwestern Linz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven CIN 1/2 * adequate colposcopy (i.e. fully visible transformation zone and margins of any visible lesion) * positive HPV test * conducted negative pregnancy test * women aged 18 to 50 years * written informed consent
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIN remission rate after treatment with TCA 85% | 6 months | measured by histologic remission within 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CIN regression rate after treatment with TCA 85% | 6 months | measured by histologic regression within 6 (improvement of at least one clinical CIN grade) months |
| Pain scores | 6 months | measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2 |
| Type specific human papillomavirus clearance rate after treatment with TCA 85% | 6 months | human papillomavirus clearance rate after treatment with TCA 85% with CIN I/CIN // within 6 months |
Countries
Austria
Outcome results
None listed