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

NCT04400578 | Completed DMC

• 1 other identifier: EKS 48/19
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia Grade 1; Cervical Intraepithelial Neoplasia Grade 2

Outcome Measures

Primary Outcomes (1)

• CIN remission rate after treatment with TCA 85%

  measured by histologic remission within 6 months

  6 months

Secondary Outcomes (3)

• 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

Study Arms (1)

TRICIN

EXPERIMENTAL

If a patient is eligible 1. local anesthesia with Xylocain 10% with a pump spray for a period of 10 seconds- one time application 2. Procain 2%: local anesthesia with a swab for a period of 10 seconds- one time application 3. Trichloroacetic acid TCA 85% 1-2 ml with soaked swab for max. 2 minutes -one time application

Device: Trichloroacetic acid 85% (TCA)

Interventions

Trichloroacetic acid 85% (TCA) DEVICE

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.

TRICIN

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krankenhaus Barmherzige Schwestern Linz: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern

Linz, 4010, Austria

Location

Study Officials

• Lukas Hefler, MD

  Krankenhaus Barmherzige Schwestern Linz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: May 22, 2020
• Study Start: February 7, 2020
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: April 7, 2022

Record last verified: 2020-03

Locations

AU (1)