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Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
University of Arkansas
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT01164722
First received: July 16, 2010
Last updated: September 9, 2016
Last verified: September 2016
Results First Received: September 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Anal Cancer
Neoplasm of Uncertain Malignant Potential
Nonneoplastic Condition
Precancerous Condition
Interventions: Other: clinical observation
Device: infrared photocoagulation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I: Infrared Coagulator Treatment

Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.

infrared photocoagulation therapy: Anal infrared coagulator ablation

Arm II: Expectant Management

Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.

clinical observation: Patients undergo observation


Participant Flow:   Overall Study
    Arm I: Infrared Coagulator Treatment   Arm II: Expectant Management
STARTED   60   60 
COMPLETED   42   45 
NOT COMPLETED   18   15 
Adverse Event                0                1 
Withdrawal by Subject                3                4 
Lost to Follow-up                3                6 
met protocol criteria for non-treatment                11                1 
enrolled on other study, concomitant med                1                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled participants

Reporting Groups
  Description
Arm I: Infrared Coagulator Treatment

Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.

infrared photocoagulation therapy: Anal infrared coagulator ablation

Arm II: Expectant Management

Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.

clinical observation: Patients undergo observation

Total Total of all reporting groups

Baseline Measures
   Arm I: Infrared Coagulator Treatment   Arm II: Expectant Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   60   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.0  (9.0)   49.0  (9.6)   49.8  (9.3) 
Gender 
[Units: Participants]
     
Female   2   6   8 
Male   58   54   112 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   6   16   22 
Not Hispanic or Latino   53   44   97 
Unknown or Not Reported   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   9   13   22 
White   46   46   92 
More than one race   3   0   3 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   60   60   120 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Response Through 1 Year   [ Time Frame: 1 year post treatment ]

2.  Secondary:   Tolerability and Safety of Infrared Coagulator Ablation   [ Time Frame: All study visits through year 2 ]

3.  Secondary:   Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year   [ Time Frame: 1 year on study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Recurrence Rate at 1 Year   [ Time Frame: 1 year on study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Incidence of Metachronous Lesions   [ Time Frame: every 3 months on study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Group Statistician
Organization: AIDS Malignancy Consortium
phone: 1-501-526-6712
e-mail: jylee@uams.edu



Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT01164722     History of Changes
Other Study ID Numbers: AMC-076
U01CA121947 ( US NIH Grant/Contract Award Number )
AMC-076 ( Other Identifier: AMC )
Study First Received: July 16, 2010
Results First Received: September 9, 2016
Last Updated: September 9, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration