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Trial record 29 of 30 for:    " July 07, 2010":" August 06, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT01164722
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : October 31, 2016
Last Update Posted : February 13, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
University of Arkansas
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 60 60
Completed 42 45
Not Completed 18 15
Reason Not Completed
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
Arm/Group Title Arm I: Infrared Coagulator Treatment Arm II: Expectant Management Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
Enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
50.0  (9.0) 49.0  (9.6) 49.8  (9.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
2
   3.3%
6
  10.0%
8
   6.7%
Male
58
  96.7%
54
  90.0%
112
  93.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Hispanic or Latino
6
  10.0%
16
  26.7%
22
  18.3%
Not Hispanic or Latino
53
  88.3%
44
  73.3%
97
  80.8%
Unknown or Not Reported
1
   1.7%
0
   0.0%
1
   0.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
American Indian or Alaska Native
1
   1.7%
0
   0.0%
1
   0.8%
Asian
1
   1.7%
0
   0.0%
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.7%
1
   0.8%
Black or African American
9
  15.0%
13
  21.7%
22
  18.3%
White
46
  76.7%
46
  76.7%
92
  76.7%
More than one race
3
   5.0%
0
   0.0%
3
   2.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Complete Response Through 1 Year
Hide Description No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.
Time Frame 1 year post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All study participants who were randomized and attended the baseline visit.
Arm/Group Title Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: participants
38 16
2.Secondary Outcome
Title Tolerability and Safety of Infrared Coagulator Ablation
Hide Description Number of patients who experienced a serious adverse events
Time Frame All study visits through year 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: participants
8 6
3.Secondary Outcome
Title Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year
Hide Description Number of patients who had high grade anal intraepithelial neoplasia at one year.
Time Frame 1 year on study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had an evaluable biopsy within one year after randomization.
Arm/Group Title Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 55 57
Measure Type: Count of Participants
Unit of Measure: Participants
15
  27.3%
40
  70.2%
4.Secondary Outcome
Title Recurrence Rate at 1 Year
Hide Description [Not Specified]
Time Frame 1 year on study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who were treated with IRC, no data were collected on patients on the expectant management arm
Arm/Group Title Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 60 0
Measure Type: Number
Unit of Measure: Percentage of lesions that recurred
37
5.Secondary Outcome
Title Incidence of Metachronous Lesions
Hide Description Number of patients with one or more metachronous lesions
Time Frame one year on study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patents with any biopsy from randomization to one year
Arm/Group Title Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 58 55
Measure Type: Count of Participants
Unit of Measure: Participants
26
  44.8%
15
  27.3%
Time Frame Study duration - maximum is 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Affected / at Risk (%) Affected / at Risk (%)
Total   8/60 (13.33%)   6/60 (10.00%) 
Blood and lymphatic system disorders     
Anemia * 1  1/60 (1.67%)  0/60 (0.00%) 
Cardiac disorders     
Acute coronary syndrome * 1  1/60 (1.67%)  0/60 (0.00%) 
Aortic Valve Disease * 1  0/60 (0.00%)  1/60 (1.67%) 
Cardiac Disorders, other * 1  1/60 (1.67%)  0/60 (0.00%) 
Myocardial infarction * 1  2/60 (3.33%)  0/60 (0.00%) 
Eye disorders     
Retinal vacular disorder * 1  0/60 (0.00%)  1/60 (1.67%) 
Gastrointestinal disorders     
Pancreatitis * 1  0/60 (0.00%)  1/60 (1.67%) 
Infections and infestations     
Infections, other * 1  1/60 (1.67%)  0/60 (0.00%) 
Injury, poisoning and procedural complications     
Fracture * 1  0/60 (0.00%)  1/60 (1.67%) 
Hip fracture * 1  0/60 (0.00%)  1/60 (1.67%) 
Intraoperative musculoskeletal injury * 1  0/60 (0.00%)  1/60 (1.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms, unspecified * 1  1/60 (1.67%)  1/60 (1.67%) 
Psychiatric disorders     
Anxiety * 1  0/60 (0.00%)  1/60 (1.67%) 
Renal and urinary disorders     
Renal calculi * 1  1/60 (1.67%)  0/60 (0.00%) 
Vascular disorders     
Thromboembolic event * 1  1/60 (1.67%)  1/60 (1.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I: Infrared Coagulator Treatment Arm II: Expectant Management
Affected / at Risk (%) Affected / at Risk (%)
Total   54/60 (90.00%)   41/60 (68.33%) 
Gastrointestinal disorders     
Anal hemorrhage * 1  4/60 (6.67%)  6/60 (10.00%) 
Anal pain * 1  49/60 (81.67%)  30/60 (50.00%) 
Anal ulcer * 1  14/60 (23.33%)  4/60 (6.67%) 
Diarrhea * 1  6/60 (10.00%)  4/60 (6.67%) 
Hemorrhoids * 1  5/60 (8.33%)  1/60 (1.67%) 
General disorders     
Flu-like symptoms * 1  3/60 (5.00%)  4/60 (6.67%) 
Infections and infestations     
Anorectal infection * 1  3/60 (5.00%)  4/60 (6.67%) 
Infections,other * 1  2/60 (3.33%)  5/60 (8.33%) 
Skin infection * 1  2/60 (3.33%)  4/60 (6.67%) 
Injury, poisoning and procedural complications     
Postoperative hemorrhage * 1  45/60 (75.00%)  20/60 (33.33%) 
Musculoskeletal and connective tissue disorders     
back pain * 1  3/60 (5.00%)  4/60 (6.67%) 
Musculoskeletal disorder, other * 1  5/60 (8.33%)  4/60 (6.67%) 
Neck pain * 1  0/60 (0.00%)  4/60 (6.67%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  4/60 (6.67%)  0/60 (0.00%) 
Skin and subcutaneous tissue disorder, other * 1  2/60 (3.33%)  6/60 (10.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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
Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT01164722     History of Changes
Other Study ID Numbers: AMC-076
U01CA121947 ( U.S. NIH Grant/Contract )
AMC-076 ( Other Identifier: AMC )
First Submitted: July 16, 2010
First Posted: July 19, 2010
Results First Submitted: September 9, 2016
Results First Posted: October 31, 2016
Last Update Posted: February 13, 2017