Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428285
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2007-01-25
Brief Title:
Tolerability Safety Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
A Phase II Prospective Open-label Pilot Study of the Tolerability Safety and Efficacy of Argon Plasma Coagulation for the Treatment of Anal Intraepithelial Neoplasia Grade 2 or 3 in HIV-positive Men Having Sex With Men
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess if argon plasma coagulation APC is a safe and well tolerated treatment method for anal intraepithelial neoplasia AIN grade 23 in HIV-positive men having sex with men MSM
Detailed Description:
HIV infected men having sex with men MSM are at increased risk of developing anal cancer compared to the general population and the incidence continues to increase despite better control of HIV infection with HAART Highly Active Anti-Retroviral Therapy The causative agent is known to be Human Papilloma Virus infection which can lead to dysplastic changes in the anus detectable by High Resolution Anoscopy with biopsies The analysis of the abnormal tissue can then be graded as Anal Intraepithelial Neoplasia 1 to 3 with AIN 2 or 3 considered as high grade dysplasia These lesions are cancer precursors but the proportion of lesions progressing to invasive anal cancer and the time to event are unknown There is currently no recognized treatment to offer as standard of care although it is of general belief that treating these lesions as it is done for women with CIN 2 and 3 Cervical Intraepithelial Neoplasia could help decrease the number of progressions to invasive anal cancer in MSM infected with HIV
By experience at our center and results of this technique for other gastrointestinal pathologies we believe Argon Plasma Coagulation APC could be a safe well tolerated and efficient treatment of high-grade dysplasia AIN 23 in HIV infected MSM
This study will assess the APC treatment in 20 patients all HIV infected MSM with established AIN 23 as confirmed with their last two anal biopsies at least 4 months apart Patients will then be followed with regular High Resolution Anoscopies for two years The primary objective is to assess if APC is a safe and well tolerated treatment method for AIN 23 in HIV-positive MSM As secondary objectives the efficacy of APC treatment on AIN 23 lesions in HIV-positive MSM the number of treatments with APC necessary to obtain regression or resolution of AIN 23 over two years and the efficacy of APC treatment to decrease anal HPV in this population will also be addressed
By experience at our center and results of this technique for other gastrointestinal pathologies we believe Argon Plasma Coagulation APC could be a safe well tolerated and efficient treatment of high-grade dysplasia AIN 23 in HIV infected MSM
This study will assess the APC treatment in 20 patients all HIV infected MSM with established AIN 23 as confirmed with their last two anal biopsies at least 4 months apart Patients will then be followed with regular High Resolution Anoscopies for two years The primary objective is to assess if APC is a safe and well tolerated treatment method for AIN 23 in HIV-positive MSM As secondary objectives the efficacy of APC treatment on AIN 23 lesions in HIV-positive MSM the number of treatments with APC necessary to obtain regression or resolution of AIN 23 over two years and the efficacy of APC treatment to decrease anal HPV in this population will also be addressed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SL06-011 CHUM | None | None | None |