Trial Outcomes & Findings for Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia (NCT NCT01164722)
NCT ID: NCT01164722
Last Updated: 2020-08-04
Results Overview
No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
1 year post treatment
Results posted on
2020-08-04
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
42
|
45
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
met protocol criteria for non-treatment
|
11
|
1
|
|
Overall Study
enrolled on other study, concomitant med
|
1
|
3
|
Baseline Characteristics
Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
Baseline characteristics by cohort
| Measure |
Arm I: Infrared Coagulator Treatment
n=60 Participants
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
n=60 Participants
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
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
49.0 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
49.8 years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=93 Participants
|
60 participants
n=4 Participants
|
120 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 year post treatmentPopulation: All study participants who were randomized and attended the baseline visit.
No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.
Outcome measures
| Measure |
Arm I: Infrared Coagulator Treatment
n=60 Participants
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
n=60 Participants
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
|
|---|---|---|
|
Complete Response Through 1 Year
|
38 participants
|
16 participants
|
SECONDARY outcome
Timeframe: All study visits through year 2Number of patients who experienced a serious adverse events
Outcome measures
| Measure |
Arm I: Infrared Coagulator Treatment
n=60 Participants
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
n=60 Participants
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
|
|---|---|---|
|
Tolerability and Safety of Infrared Coagulator Ablation
|
8 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 1 year on studyPopulation: Patients who had an evaluable biopsy within one year after randomization.
Number of patients who had high grade anal intraepithelial neoplasia at one year.
Outcome measures
| Measure |
Arm I: Infrared Coagulator Treatment
n=55 Participants
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
n=57 Participants
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
|
|---|---|---|
|
Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year
|
15 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 1 year on studyPopulation: Patients who were treated with IRC, no data were collected on patients on the expectant management arm
Outcome measures
| Measure |
Arm I: Infrared Coagulator Treatment
n=60 Participants
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
|
|---|---|---|
|
Recurrence Rate at 1 Year
|
37 Percentage of lesions that recurred
|
—
|
SECONDARY outcome
Timeframe: one year on studyPopulation: Patents with any biopsy from randomization to one year
Number of patients with one or more metachronous lesions
Outcome measures
| Measure |
Arm I: Infrared Coagulator Treatment
n=58 Participants
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
n=55 Participants
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
|
|---|---|---|
|
Incidence of Metachronous Lesions
|
26 Participants
|
15 Participants
|
Adverse Events
Arm I: Infrared Coagulator Treatment
Serious events: 8 serious events
Other events: 54 other events
Deaths: 0 deaths
Arm II: Expectant Management
Serious events: 6 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Infrared Coagulator Treatment
n=60 participants at risk
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
n=60 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/60 • Study duration - maximum is 24 months
|
0.00%
0/60 • Study duration - maximum is 24 months
|
|
Cardiac disorders
Acute coronary syndrome
|
1.7%
1/60 • Study duration - maximum is 24 months
|
0.00%
0/60 • Study duration - maximum is 24 months
|
|
Cardiac disorders
Aortic Valve Disease
|
0.00%
0/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
Cardiac disorders
Cardiac Disorders, other
|
1.7%
1/60 • Study duration - maximum is 24 months
|
0.00%
0/60 • Study duration - maximum is 24 months
|
|
Cardiac disorders
Myocardial infarction
|
3.3%
2/60 • Study duration - maximum is 24 months
|
0.00%
0/60 • Study duration - maximum is 24 months
|
|
Eye disorders
Retinal vacular disorder
|
0.00%
0/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
Infections and infestations
Infections, other
|
1.7%
1/60 • Study duration - maximum is 24 months
|
0.00%
0/60 • Study duration - maximum is 24 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury
|
0.00%
0/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, unspecified
|
1.7%
1/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
Renal and urinary disorders
Renal calculi
|
1.7%
1/60 • Study duration - maximum is 24 months
|
0.00%
0/60 • Study duration - maximum is 24 months
|
|
Vascular disorders
Thromboembolic event
|
1.7%
1/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
Other adverse events
| Measure |
Arm I: Infrared Coagulator Treatment
n=60 participants at risk
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
n=60 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Anal hemorrhage
|
6.7%
4/60 • Study duration - maximum is 24 months
|
10.0%
6/60 • Study duration - maximum is 24 months
|
|
Gastrointestinal disorders
Anal pain
|
81.7%
49/60 • Study duration - maximum is 24 months
|
50.0%
30/60 • Study duration - maximum is 24 months
|
|
Gastrointestinal disorders
Anal ulcer
|
23.3%
14/60 • Study duration - maximum is 24 months
|
6.7%
4/60 • Study duration - maximum is 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
6/60 • Study duration - maximum is 24 months
|
6.7%
4/60 • Study duration - maximum is 24 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
5/60 • Study duration - maximum is 24 months
|
1.7%
1/60 • Study duration - maximum is 24 months
|
|
General disorders
Flu-like symptoms
|
5.0%
3/60 • Study duration - maximum is 24 months
|
6.7%
4/60 • Study duration - maximum is 24 months
|
|
Infections and infestations
Anorectal infection
|
5.0%
3/60 • Study duration - maximum is 24 months
|
6.7%
4/60 • Study duration - maximum is 24 months
|
|
Infections and infestations
Infections,other
|
3.3%
2/60 • Study duration - maximum is 24 months
|
8.3%
5/60 • Study duration - maximum is 24 months
|
|
Infections and infestations
Skin infection
|
3.3%
2/60 • Study duration - maximum is 24 months
|
6.7%
4/60 • Study duration - maximum is 24 months
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
75.0%
45/60 • Study duration - maximum is 24 months
|
33.3%
20/60 • Study duration - maximum is 24 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.0%
3/60 • Study duration - maximum is 24 months
|
6.7%
4/60 • Study duration - maximum is 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder, other
|
8.3%
5/60 • Study duration - maximum is 24 months
|
6.7%
4/60 • Study duration - maximum is 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/60 • Study duration - maximum is 24 months
|
6.7%
4/60 • Study duration - maximum is 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
4/60 • Study duration - maximum is 24 months
|
0.00%
0/60 • Study duration - maximum is 24 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorder, other
|
3.3%
2/60 • Study duration - maximum is 24 months
|
10.0%
6/60 • Study duration - maximum is 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place