Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066430
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2003-08-06
Brief Title:
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia HSIL in the Anal Canal In HIV Infected Individuals A Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-09
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:
RATIONALE Infrared coagulation may be effective in preventing the development of anal cancer in patients who have anal neoplasia
PURPOSE Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia
PURPOSE Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia
Detailed Description:
OBJECTIVES
Determine the recurrence rate of high-grade squamous intraepithelial neoplasia in the anal canal of HIV-positive patients treated with infrared coagulation
Determine the time to recurrence and time to progression in patients treated with this procedure
Determine the toxicity of this procedure in these patients
Correlate CD4CD8 count and HIV viral load with outcome in patients treated with this procedure
Correlate outcome with human papilloma virus subtype in patients treated with this procedure
OUTLINE This is an open-label pilot multicenter study
Patients undergo treatment with an infrared coagulator in direct contact with the lesion for 15 seconds and necrotic tissue is then debrided Treatment repeats to the level of the submucosal vessels under colposcopic guidance A repeat biopsy is performed at 3 months to assess treatment success Patients with incompletely treated lesions receive 1 more treatment Up to 3 lesions are treated during each visit in the absence of disease progression or unacceptable toxicity
Patients complete questionnaires regarding anal pain and discomfort at baseline at 4 weeks and at 3 6 9 and 12 months
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study within 6 months
Determine the recurrence rate of high-grade squamous intraepithelial neoplasia in the anal canal of HIV-positive patients treated with infrared coagulation
Determine the time to recurrence and time to progression in patients treated with this procedure
Determine the toxicity of this procedure in these patients
Correlate CD4CD8 count and HIV viral load with outcome in patients treated with this procedure
Correlate outcome with human papilloma virus subtype in patients treated with this procedure
OUTLINE This is an open-label pilot multicenter study
Patients undergo treatment with an infrared coagulator in direct contact with the lesion for 15 seconds and necrotic tissue is then debrided Treatment repeats to the level of the submucosal vessels under colposcopic guidance A repeat biopsy is performed at 3 months to assess treatment success Patients with incompletely treated lesions receive 1 more treatment Up to 3 lesions are treated during each visit in the absence of disease progression or unacceptable toxicity
Patients complete questionnaires regarding anal pain and discomfort at baseline at 4 weeks and at 3 6 9 and 12 months
Patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study within 6 months
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 |
|---|---|---|---|
| CDR0000316109 | OTHER | NCI | None |