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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

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.


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Grade 1 Cervical Intraepithelial Neoplasia Grade 2 Device: Trichloroacetic acid 85% (TCA) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 101 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 7, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. CIN remission rate after treatment with TCA 85% [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. CIN regression rate after treatment with TCA 85% [ Time Frame: 6 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400578


Contacts
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Contact: Laudia Hadjari +43 732 7677 0 ext 4681 laudia.hadjari@ordensklinikum.at

Locations
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Austria
Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern Recruiting
Linz, Austria, 4010
Contact: Lukas Hefler, MD    +43 732 7677 0 ext 7160    lukas.hefler@ordensklinikum.at   
Contact: Laudia Hadjari    +43 732 7677 0 ext 4681    laudia.hadjari@ordensklinikum.at   
Sponsors and Collaborators
Krankenhaus Barmherzige Schwestern Linz
Medical University of Vienna
Investigators
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Principal Investigator: Lukas Hefler, MD Krankenhaus Barmherzige Schwestern Linz
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Responsible Party: Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier: NCT04400578    
Other Study ID Numbers: EKS 48/19
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type