TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

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

  • Device: Trichloroacetic 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.

Arms, Groups and Cohorts

  • Experimental: TRICIN
    • If a patient is eligible local anesthesia with Xylocain 10% with a pump spray for a period of 10 seconds- one time application Procain 2%: local anesthesia with a swab for a period of 10 seconds- one time application Trichloroacetic acid TCA 85% 1-2 ml with soaked swab for max. 2 minutes -one time application

Clinical Trial Outcome Measures

Primary Measures

  • CIN remission rate after treatment with TCA 85%
    • Time Frame: 6 months

Secondary Measures

  • CIN regression rate after treatment with TCA 85%
    • Time Frame: 6 months
  • Pain scores
    • Time Frame: 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%
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Krankenhaus Barmherzige Schwestern Linz
  • Collaborator
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lukas Hefler, MD, Principal Investigator, Krankenhaus Barmherzige Schwestern Linz
  • Overall Contact(s)
    • Laudia Hadjari, +43 732 7677 0, laudia.hadjari@ordensklinikum.at

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