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

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 Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia Grade 1; Cervical Intraepithelial Neoplasia Grade 2
• Intervention / Treatment: Device: Trichloroacetic acid 85% (TCA)

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

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4010
    • Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CIN remission rate after treatment with TCA 85%	measured by histologic remission within 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CIN regression rate after treatment with TCA 85%	measured by histologic regression within 6 (improvement of at least one clinical CIN grade) months	6 months
Pain scores	measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2	6 months
Type specific human papillomavirus clearance rate after treatment with TCA 85%	human papillomavirus clearance rate after treatment with TCA 85% with CIN I/CIN // within 6 months	6 months

Collaborators and Investigators

• Sponsor: Krankenhaus Barmherzige Schwestern Linz
• Collaborators: Medical University of Vienna
• Investigators: Principal Investigator: Lukas Hefler, MD, Krankenhaus Barmherzige Schwestern Linz

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: EKS 48/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No