Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188104
Status:
WITHDRAWN
Last Update Posted:
2024-01-03
First Post:
2023-09-29
Brief Title:
Efficacy of Topical 95 TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test
Sponsor:
Rajavithi Hospital
Organization:
Rajavithi Hospital
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
I have found it is quite difficult to conduct the work without changing some detail in original protocol So we would like to re-start the study again with some modification
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 95Trichloroacetic acid and at the time of follow-up If positive at any point of time participants are excluded from the study
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 eg 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 95Trichloroacetic acid and at the time of follow-up If positive at any point of time participants are excluded from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None