Efficacy of Topical 95% TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test
- Registration Number
- NCT06188104
- Lead Sponsor
- Rajavithi Hospital
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TCA plus acetic acid 3 Trichloroacetic acid Having lesion with low-grade abnomality on pathologic examination, TCA plus acetic acid 2 Trichloroacetic acid Having lesion with normal pathologic examination TCA plus acetic acid 1 Trichloroacetic acid No lesion group,
- Primary Outcome Measures
Name Time Method 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) 6 months after intervention using cytologic examination, HPV testing and colposcopic examination with biopsy (if having lesion) compare to previous results
If all of the test's results are normal, we consider it as remission of CIN1 or less
\*normal means: Cytologic examination = Negative for intraepithelial lesion or malignancy HPV testing = no HPV detected Colposcopic examination not seen any lesion = normal (not perform biopsy) Colposcopic examination with biopsy = normal pathlogic result
- Secondary Outcome Measures
Name Time Method Having abnormal vaginal bleeding or not? which is recorded by questionnaire immediately after intervention, up to 2 weeks after intervention Sides effect of 95%Trichloroacetic acid
Pain after treatment which evaluated by using visual analogue scale immediately after intervention, up to 2 weeks after intervention Sides effect of 95%Trichloroacetic acid
Having leukorrhea or not? which is recorded by questionnaire immediately after intervention, up to 2 weeks after intervention Sides effect of 95%Trichloroacetic acid
Trial Locations
- Locations (1)
Rajavithi hospital
🇹ðŸ‡Phaya Thai, Bangkok, Thailand