Screening Women With Prior HPV for Anal Neoplasia

Study Overview
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Brief Summary
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The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.

Detailed Description
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This single arm trial will enroll 300 HIV uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, HPV testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. Participants will undergo evaluation at baseline and then at 12 and 24 months. The investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. The trial is expected to run from 2021-2025.

Official Title
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The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors

Conditions
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HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias, Early Stage Lower Genital Tract Cancers

Intervention / Treatment
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* Diagnostic Test: Diagnostic tests for anal cancer screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer) Documented HIV seronegativity Aged 35 years and older Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston English or Spanish speaking

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women With Prior HPV for Anal Neoplasia<br>Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy. | Diagnostic Test: Diagnostic tests for anal cancer screening<br>* The initial screening interventions will include the collection of (1) anal cytology; (2) self-collected HPV testing specimens (by subjects); (3) a clinician collected HPV specimen. A digital rectal exam will also be done on all patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of anal cytology | Test sensitivity and specificity | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of self- and clinician-collected PCR testing | Proportionate concordance of high-risk HPV testing | baseline | 
| Prevalence of hrHPV types at baseline | Proportion of subjects with high-risk HPV and subtype proportions | Baseline | 
| hrHPV with Cobas PCR testing (self-collected) | Presence of high-risk HPV subtype | Baseline | 
| hrHPV with Cobas PCR testing (self-collected) | Presence of high-risk HPV subtype | 12 months | 
| hrHPV with Cobas PCR testing (self-collected) | Presence of high-risk HPV subtype | 24 months | 
| hrHPV with Cobas PCR testing (clinician-collected) | Presence of high-risk HPV subtype | Baseline | 
| hrHPV with Cobas PCR testing (clinician-collected) | Presence of high-risk HPV subtype | 12 months | 
| hrHPV with Cobas PCR testing (clinician-collected) | Presence of high-risk HPV subtype | 24 months | 
| Prevalence of aHSIL at baseline | Proportion of subjects with aHSIL | Baseline | 
| Incidence of aHSIL at follow-up | Proportion of subjects with new aHSIL during follow-up period | 24 months | 
| Screening Experience Survey | Survey measures anal cancer screening test acceptability. Each item is scored 0-3, with higher score indicting more acceptability. 0-3. There is no total scale. Each question is scored separately and the overall results are used qualitatively. | Baseline | 
| Incidence of hrHPV, by type | Proportion of subjects with new hrHPV infection | 12 months | 
| Incidence of hrHPV, by type | Proportion of subjects with new hrHPV infection | 24 months | 
| Proportion of subjects with new hrHPV infection | Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up | 12 months | 
| Proportion of subjects with new hrHPV infection | Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal cancer, anal precancerous, anal high grade intraepithelial lesion, anal cytology, high resolution anoscopy, anal human papilloma virus testing