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

Cervical Intraepithelial Neoplasia Grade 2 Clinical Trial

— TRICIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400578
• Other study ID #: EKS 48/19
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: January 18, 2022

Study information

• Verified date: March 2020
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 1
• Cervical Intraepithelial Neoplasia Grade 2
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Austria	Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern	Linz

Sponsors (2)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIN remission rate after treatment with TCA 85%	measured by histologic remission within 6 months	6 months
Secondary	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
Secondary	Pain scores	measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2	6 months
Secondary	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