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

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ClinicalTrials.gov Identifier: NCT04400578
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Krankenhaus Barmherzige Schwestern Linz

Tracking Information
First Submitted Date  ICMJE March 17, 2020
First Posted Date  ICMJE May 22, 2020
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE February 7, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
CIN remission rate after treatment with TCA 85% [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)
Official Title  ICMJE TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Intraepithelial Neoplasia Grade 1
  • Cervical Intraepithelial Neoplasia Grade 2
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: TRICIN

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
Intervention: Device: Trichloroacetic acid 85% (TCA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2020)
101
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laudia Hadjari +43 732 7677 0 ext 4681 laudia.hadjari@ordensklinikum.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04400578
Other Study ID Numbers  ICMJE EKS 48/19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Krankenhaus Barmherzige Schwestern Linz
Study Sponsor  ICMJE Krankenhaus Barmherzige Schwestern Linz
Collaborators  ICMJE Medical University of Vienna
Investigators  ICMJE
Principal Investigator: Lukas Hefler, MD Krankenhaus Barmherzige Schwestern Linz
PRS Account Krankenhaus Barmherzige Schwestern Linz
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP