TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)
Condition: Cervical Intraepithelial Neoplasia Grade 1; Cervical Intraepithelial Neoplasia Grade 2
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional

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
    

Intervention name(s): Trichloroacetic acid 85% (TCA)
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment