TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- CIN remission rate after treatment with TCA 85%
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts 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
- •Exclusion criteria are a cytologically suspected CIN (Pap IIID, IV)
- •inadequate colposcopy
- •negative or missing biopsy
- •cytology results indicating invasive disease (PAP V)
- •if the cervical lesion recedes into the endocervical canal
- •pregnancy
- •any medical circumstance considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator
Outcomes
Primary Outcomes
CIN remission rate after treatment with TCA 85%
Time Frame: 6 months
measured by histologic remission within 6 months
Secondary Outcomes
- CIN regression rate after treatment with TCA 85%(6 months)
- Pain scores(6 months)
- Type specific human papillomavirus clearance rate after treatment with TCA 85%(6 months)