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NCT Number: NCT04400578

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

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Grade 1 Cervical Intraepithelial Neoplasia Grade 2

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Linz, 4010, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. CIN remission rate after treatment with TCA 85%

    Time frame: 6 months

    measured by histologic remission within 6 months

Secondary outcomes

  1. CIN regression rate after treatment with TCA 85%

    Time frame: 6 months

    measured by histologic regression within 6 (improvement of at least one clinical CIN grade) months

  2. Pain scores

    Time frame: 6 months

    measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2

  3. Type specific human papillomavirus clearance rate after treatment with TCA 85%

    Time frame: 6 months

    human papillomavirus clearance rate after treatment with TCA 85% with CIN I/CIN // within 6 months

Sponsors and collaborators

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Other

Collaborators

  • Medical University of Vienna

Registry information

Acronym: TRICIN

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 22, 2020
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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