Clinical trial NCT04400578: 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: TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia Grade 1
Cervical Intraepithelial Neoplasia Grade 2
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2020-05-22
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: CIN remission rate after treatment with TCA 85%
timeFrame: 6 months
Secondary outcomes:
measure: CIN regression rate after treatment with TCA 85%
timeFrame: 6 months
measure: Pain scores
timeFrame: 6 months
measure: Type specific human papillomavirus clearance rate after treatment with TCA 85%
timeFrame: 6 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern
Study officials:
affiliation: Krankenhaus Barmherzige Schwestern Linz
name: Lukas Hefler, MD
role: PRINCIPAL_INVESTIGATOR
References: