The Effectiveness of High Resolution Microendoscopy for People Living With HIV
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| ClinicalTrials.gov Identifier: NCT04563754 |
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Recruitment Status :
Recruiting
First Posted : September 24, 2020
Last Update Posted : September 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anal High Grade Squamous Intraepithelial Lesion | Diagnostic Test: mHRME (Mobile High resolution microendoscope) | Phase 2 |
The investigators' central hypothesis is that using mHRME plus 3D mapping as a diagnostic tool will improve the accuracy and efficiency of HSIL diagnoses.
Additionally, the investigators hypothesize that the sensitivity (SN) specificity (SP), positive predictive value (PPV) and negative predictive value (NPV), as well as the receiver operating curve for the identification of neoplasia on a per biopsy and per patient basis will be high.The investigators will first compare the HRA-directed biopsy (as the gold standard) to the results of the mHRME HSIL diagnosis. The SN of mHRME diagnosis in detection of HSIL will be estimated with the binomial proportion of study participants who are positive for HSIL on HRA-guided biopsy at two thresholds of histology thresholds which are: 1) AIN (Anal intraepithelial neoplasia) 2+ threshold, and 2) AIN3+ threshold. SP will be estimated as the proportion of study participants who are negative for HSIL on HRA-guided biopsy at both thresholds. Positive and negative predictive values will be estimated using the binomial proportion and its 95% confidence interval (CI). In addition, the Cohens kappa statistic, and receiver operator characteristic curves will be generated if patient characteristics such as low CD4 count, cART (combined antiretroviral treatment) utilization, or high HIV viral load impact the determination of SN and SP. SN and SP of mHRME-based HSIL diagnosis will be estimated on a per lesion and per patient basis with 95% CI and compared by McNemar's test. A generalized linear model for logistic regression with multiple correlated outcomes will compare SN and SP of each method on a per biopsy and per patient basis.
Primary Objective To determine if the mHRME plus 3D mapping improves the accuracy of anal HSIL diagnosis compared to the gold standard of histologic diagnosis of HSIL by high resolution anoscopy (HRA)-guided biopsy
Secondary Objectives
Determination whether HRME changes the decision to perform biopsy
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | The Effectiveness of High Resolution Microendoscopy (HRME) in High Grade Intraepithelial Lesions (HSIL) Diagnosis for People Living With HIV |
| Actual Study Start Date : | July 1, 2019 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | November 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: mHRME and HRA
5-10 ml of proflavine hemisulfate (0.01%) will be applied on the anal epithelium. The mHRME will then be inserted and imaging of abnormal tissues will be performed. This is a single-arm study where all subjects will receive both standard of care HRA (High resolution anoscopy) and experimental mHRME imaging. |
Diagnostic Test: mHRME (Mobile High resolution microendoscope)
SOC (standard of care) HRA with Lugol's iodine will be performed. Unstained (abnormal) area will be evaluated with mHRME for optical biopsy diagnosis: 1) contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)).2)The mHRME will then be inserted and imaging of abnormal tissues will be performed. This will add 2 to 6 minutes per procedure. This is a single-arm study where all subjects will receive both standard of care HRA (High resolution anoscopy) and experimental mHRME imaging. Other Name: Anoscopy |
- Performance characteristics: Sensitivity (SN), Specificity (SP), positive predictive value (PPV) and negative predictive values (NPV) [ Time Frame: Day 1 ]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
- Procedure efficiency [ Time Frame: Day 1 ]Diagnostic yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.
- Procedure time [ Time Frame: Day 1 ]Change in total procedure time for HRA plus mHRME vs HRA guided biopsy
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Consentable patients with documented HIV disease
- Either: 1) previously documented HSIL or 2) abnormal anal cytology within the past 2 years
- Ages 18 years and older
- Seen at the Baylor-affiliated Thomas Street Clinic (TSC), Mount Sinai Hospital and affiliated clinics
Exclusion Criteria:
- Unable to undergo routine anoscopy
- Allergy or prior reaction to the fluorescent contrast agent Proflavine or Iodine
- Unable to give informed consent
- Current or prior history of Invasive Anal Cancer
- Known permanent or irreversible bleeding disorder, or other hematologic disorder that in the opinion of the investigator would place the patient at increased risk for adverse outcome from the procedure
- Pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563754
| Contact: Sharmilla Anandasabapathy, MD | 7137980950 | Sharmila.Anandasabapathy@bcm.edu | |
| Contact: Elizabeth Y Chiao, MD | 7137921860 | eychiao@mdanderson.org |
| United States, New York | |
| Icahn School of Medicine at Mount Sinai | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Courtney Chan 212-241-3150 courtney.chan@mountsinai.org | |
| Principal Investigator: Michael M Gaisa, MD | |
| United States, Texas | |
| Baylor | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Zoe Wilhelm 713-798-7542 zwilhelm@bcm.edu | |
| Contact: suchismita Raychaudhury 713-440-4624 raychaud@bcm.edu | |
| Principal Investigator: Elizabeth Y Chiao, MD | |
| Principal Investigator: | Sharmilla Anandasabapathy, MD | Baylor College of Medicine | |
| Principal Investigator: | Elizabeth Y Chiao, MD | M.D. Anderson Cancer Center |
Documents provided by Elizabeth Chiao, Baylor College of Medicine:
| Responsible Party: | Elizabeth Chiao, Professor of Medicine, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT04563754 |
| Other Study ID Numbers: |
H-44616 |
| First Posted: | September 24, 2020 Key Record Dates |
| Last Update Posted: | September 8, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Squamous Intraepithelial Lesions of the Cervix Carcinoma, Squamous Cell Carcinoma in Situ Uterine Cervical Dysplasia Precancerous Conditions Neoplasms |
Uterine Cervical Diseases Uterine Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell |