Trial Outcomes & Findings for The Effectiveness of High Resolution Microendoscopy for People Living With HIV (NCT NCT04563754)
NCT ID: NCT04563754
Last Updated: 2025-04-23
Results Overview
The primary outcome of this study is to measure the operating characteristics including SN, SP, PPV and NPV comparing the physician- and algorithm- guided HRME-based image compared to the Lugol's- guided physician diagnosis of HSIL during HRA. Gold standard consensus pathology was used and pathology data needs to be obtained, verified, and entered.
COMPLETED
PHASE1/PHASE2
163 participants
1 day
2025-04-23
Participant Flow
Participants were recruited at two anal dysplasia clinics: Tisch Cancer Institute Mount Sinai in New York, NY, and Thomas Street Health Center in Houston, TX. At Tisch Cancer Institute Mount Sinai, participants were recruited between July 30, 2019, and September 28, 2021. At Thomas Street Health Center, participants were recruited between December 8, 2021, and March 28, 2023. Participants were consented and screened for eligibility at time of presentation to the two recruitment sites.
Participant milestones
| Measure |
Tisch Cancer Institute Mount Sinai
Participants enrolled in the Tisch Cancer Institute Mount Sinai.
|
Thomas Street Health Center
Participants enrolled in the Thomas Street Health Center, excluding the first 18 participants used as test subjects.
|
Training Set Cohort
The first 18 participants enrolled in the Thomas Street Health Center as test subjects.
|
|---|---|---|---|
|
HRME Procedure
STARTED
|
79
|
66
|
18
|
|
HRME Procedure
COMPLETED
|
68
|
60
|
0
|
|
HRME Procedure
NOT COMPLETED
|
11
|
6
|
18
|
|
Follow up
STARTED
|
79
|
66
|
18
|
|
Follow up
COMPLETED
|
18
|
13
|
13
|
|
Follow up
NOT COMPLETED
|
61
|
53
|
5
|
Reasons for withdrawal
| Measure |
Tisch Cancer Institute Mount Sinai
Participants enrolled in the Tisch Cancer Institute Mount Sinai.
|
Thomas Street Health Center
Participants enrolled in the Thomas Street Health Center, excluding the first 18 participants used as test subjects.
|
Training Set Cohort
The first 18 participants enrolled in the Thomas Street Health Center as test subjects.
|
|---|---|---|---|
|
HRME Procedure
No HRA and/or HRME data due to technical difficulties or quality control issues with HRME imaging
|
11
|
6
|
0
|
|
HRME Procedure
Optimization/validation of 3D imaging and HRME
|
0
|
0
|
18
|
|
Follow up
Lost to Follow-up
|
61
|
23
|
5
|
|
Follow up
Death
|
0
|
2
|
0
|
|
Follow up
Ongoing
|
0
|
28
|
0
|
Baseline Characteristics
The Effectiveness of High Resolution Microendoscopy for People Living With HIV
Baseline characteristics by cohort
| Measure |
Tisch Cancer Institute Mount Sinai
n=79 Participants
Participants enrolled in the Tisch Cancer Institute Mount Sinai.
|
Thomas Street Health Center
n=66 Participants
Participants enrolled in the Thomas Street Health Center, excluding the first 18 participants used as test subjects.
|
Training Set Cohort
n=18 Participants
The first 18 participants enrolled in the Thomas Street Health Center as test subjects.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.0 years
n=5 Participants
|
48.0 years
n=7 Participants
|
50.5 years
n=5 Participants
|
47.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The training set cohort (n=18) was used to optimize and develop the automated algorithms assessed for primary and secondary outcomes in the actual clinical study. In both the training set cohort and the clinical study, subjects unable to complete the HRME examination or undergo evaluation with the automated algorithm (n=26) were excluded. The remaining 137 evaluable subjects had images assessed by the algorithm and were analyzed separately by study site and the training set cohort.
The primary outcome of this study is to measure the operating characteristics including SN, SP, PPV and NPV comparing the physician- and algorithm- guided HRME-based image compared to the Lugol's- guided physician diagnosis of HSIL during HRA. Gold standard consensus pathology was used and pathology data needs to be obtained, verified, and entered.
Outcome measures
| Measure |
Tisch Cancer Institute Mount Sinai
n=101 Biopsies
Participants enrolled in the Tisch Cancer Institute Mount Sinai.
|
Thomas Street Health Center
n=126 Biopsies
Participants enrolled in the Thomas Street Health Center, excluding the first 18 participants used as test subjects.
|
Training Set Cohort
n=20 Biopsies
The first 18 participants enrolled in the Thomas Street Health Center as test subjects.
|
|---|---|---|---|
|
Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)
HRA - SN
|
90.0 percentage of biopsies
Interval 76.3 to 97.2
|
76.9 percentage of biopsies
Interval 56.4 to 91.0
|
100.0 percentage of biopsies
Interval 66.4 to 100.0
|
|
Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)
HRA - SP
|
65.6 percentage of biopsies
Interval 52.3 to 77.3
|
48.0 percentage of biopsies
Interval 37.9 to 58.2
|
90.9 percentage of biopsies
Interval 58.7 to 99.8
|
|
Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)
HRA - PPV
|
63.2 percentage of biopsies
Interval 49.3 to 75.6
|
27.8 percentage of biopsies
Interval 17.9 to 39.6
|
90.0 percentage of biopsies
Interval 55.5 to 99.7
|
|
Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)
HRA - NPV
|
90.9 percentage of biopsies
Interval 78.3 to 97.5
|
88.9 percentage of biopsies
Interval 77.4 to 95.8
|
100.0 percentage of biopsies
Interval 69.2 to 100.0
|
|
Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)
HRME - SN
|
90.0 percentage of biopsies
Interval 76.3 to 97.2
|
92.3 percentage of biopsies
Interval 74.9 to 99.1
|
100.0 percentage of biopsies
Interval 66.4 to 100.0
|
|
Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)
HRME - SP
|
67.2 percentage of biopsies
Interval 54.0 to 78.7
|
68.0 percentage of biopsies
Interval 57.9 to 77.0
|
100.0 percentage of biopsies
Interval 71.5 to 100.0
|
|
Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)
HRME - PPV
|
64.3 percentage of biopsies
Interval 50.4 to 76.6
|
42.9 percentage of biopsies
Interval 29.7 to 56.8
|
100.0 percentage of biopsies
Interval 66.4 to 100.0
|
|
Performance Characteristics: Sensitivity (SN), Specificity (SP), Positive Predictive Value (PPV) and Negative Predictive Values (NPV)
HRME - NPV
|
91.1 percentage of biopsies
Interval 78.8 to 97.5
|
97.1 percentage of biopsies
Interval 90.1 to 99.7
|
100.0 percentage of biopsies
Interval 71.5 to 100.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The training set cohort (n=18) was used to optimize and develop the automated algorithms assessed for primary and secondary outcomes in the actual clinical study. In both the training set cohort and the clinical study, subjects unable to complete the HRME examination or undergo evaluation with the automated algorithm (n=26) were excluded. The remaining 137 evaluable subjects had images assessed by the algorithm and were analyzed separately by study site and the training set cohort.
Diagnostic yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.
Outcome measures
| Measure |
Tisch Cancer Institute Mount Sinai
n=101 Biopsies
Participants enrolled in the Tisch Cancer Institute Mount Sinai.
|
Thomas Street Health Center
n=126 Biopsies
Participants enrolled in the Thomas Street Health Center, excluding the first 18 participants used as test subjects.
|
Training Set Cohort
n=20 Biopsies
The first 18 participants enrolled in the Thomas Street Health Center as test subjects.
|
|---|---|---|---|
|
Procedure Efficiency
|
39.6 percentage of biopsies
Interval 30.0 to 49.8
|
20.6 percentage of biopsies
Interval 13.9 to 28.8
|
45.0 percentage of biopsies
Interval 23.1 to 68.5
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The training set cohort (n=18) was used to optimize and develop the automated algorithms assessed for primary and secondary outcomes in the actual clinical study. In both the training set cohort and the clinical study, subjects who did not have both the procedure start and end times recorded were excluded (n=10). The remaining 153 subjects were analyzed separately by study site and the training set cohort.
Total procedure time (HRA+HRME+biopsies) vs HRME time alone
Outcome measures
| Measure |
Tisch Cancer Institute Mount Sinai
n=77 Participants
Participants enrolled in the Tisch Cancer Institute Mount Sinai.
|
Thomas Street Health Center
n=61 Participants
Participants enrolled in the Thomas Street Health Center, excluding the first 18 participants used as test subjects.
|
Training Set Cohort
n=15 Participants
The first 18 participants enrolled in the Thomas Street Health Center as test subjects.
|
|---|---|---|---|
|
Procedure Time
Total procedure time
|
8 minutes
Interval 6.0 to 13.0
|
12 minutes
Interval 10.0 to 15.0
|
17 minutes
Interval 13.0 to 18.0
|
|
Procedure Time
HRME time
|
2 minutes
Interval 1.0 to 3.0
|
4 minutes
Interval 3.0 to 5.0
|
5 minutes
Interval 4.0 to 6.0
|
Adverse Events
Tisch Cancer Institute Mount Sinai
Thomas Street Health Center
Training Set Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sharmila Anandasabapathy
Baylor College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place