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

Phase

N/A

Condition

Genitourinary Cancer

Neoplasms

Cervical Intraepithelial Neoplasia

Treatment

N/A

Clinical Study ID

NCT04400578

EKS 48/19

Ages 18-50
Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Histologically proven CIN 1/2
adequate colposcopy (i.e. fully visible transformation zone and margins of any visiblelesion)
positive HPV test
conducted negative pregnancy test
women aged 18 to 50 years
written informed consent

Exclusion

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, orrisks to the patient, at the discretion of the investigator

Study Design

February 07, 2020

January 18, 2022

Study 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

Connect with a study center

Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern
Linz, 4010
Austria
Site Not Available

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