Clinical trial NCT06188104: Efficacy of Topical 95% TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test
Official title: Efficacy of Topical 95% Trichloroaceteic Acid in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: CIN1
Trichloroacetic Acid
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2024-01-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test

Detailed description: The patients meeting inclusion criteria were initially divided into two groups which are no lesion and having lesion at cervix on colposcopic examination.

Participant in no lesion group were divided into two group, recieving 95% Trichloroacetic acid (intervention) plus aceteic acid (commonly apply at cervix during colposcopic examination) applying to the cervix at T-zone and Acetic acid alone group.

We follow-up each group for 6 months to evaluate the outcome using cytologic examination, HPV testing and colposcopic examination (also biopsy if lesion is seen) compare to previous result (before treatment)

In the group having lesion at cervix, we initially biopsy the lesion and wait for pathologic result. If the pathologic results are high-grade lesion e.g. HSIL, we exclude them from this study. On the contrary, if the pathologic result s are low-grade lesion, we divided them into two group, normal pathologic exam and low-grade abnormality on pathologic examination. Both of them are divided into two groups and follow-up for 6 months, similar to the no lesion group

\* During colposcopic examination, we also repeat cytologic examination and HPV testing as well

\*\* Pregnancy test is done before applying 95%Trichloroacetic acid and at the time of follow-up. If positive at any point of time, participants are excluded from the study

Eligibility criteria: Inclusion Criteria:

* Women who have low-grade abnormality result such as ASC-US, LSIL, HPV 16/18 positive, persistent HPV infection after cervical cancer screening test
* No history of endometrial or cervical cancer
* Pregnancy test negative
* Good communication in Thai language
* Vouluntarily participate to the study

Exclusion Criteria:

* Pregnancy test positive after participate in the study
* Pathologic result from colposcopic biopsy (before intervention) is high-grade abnormality such as HSIL, CIN2-3 or AIS

Primary outcomes:
measure: Number of participants with cytologic examination, HPV testing and colposcopic examination with biopsy ( Efficacy of 95%Trichloroacetic acid in the treatment of CIN1 or less)
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Pain after treatment which evaluated by using visual analogue scale
timeFrame: immediately after intervention, up to 2 weeks after intervention
measure: Having leukorrhea or not? which is recorded by questionnaire
timeFrame: immediately after intervention, up to 2 weeks after intervention
measure: Having abnormal vaginal bleeding or not? which is recorded by questionnaire
timeFrame: immediately after intervention, up to 2 weeks after intervention
Other outcomes:
Locations:
city: Phaya Thai
country: Thailand
facility: Rajavithi hospital
state: Bangkok
Study officials:
References: