The Effectiveness of High Resolution Microendoscopy for People Living With HIV

  • STATUS
    Recruiting
  • End date
    Nov 18, 2023
  • participants needed
    200
  • sponsor
    Baylor College of Medicine
Updated on 18 September 2021

Summary

The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated with neoplasia. The investigators' central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of HRA (High resolution anoscopy)-guided biopsy thus facilitating usage by less-experienced clinicians in community-based or low-resource settings. To validate this, the investigators will conduct a study to determine the efficiency and diagnostic characteristics of the mHRME 'optical biopsy' approach versus the current standard of HRA-based tissue biopsy. Successful results will allow for improved efficacy and resource utilization for cancer screening in people living with HIV for anal cancer and other epithelial cancers including the cervix, oral cavity, bladder, and GI tract.

Description

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

Details
Condition Anal High Grade Squamous Intraepithelial Lesion
Treatment mHRME (Mobile High resolution microendoscope)
Clinical Study IdentifierNCT04563754
SponsorBaylor College of Medicine
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

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
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