Screening Women With Prior HPV for Anal Neoplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic tests for anal cancer screening.
- Who it may be relevant to
- Registry conditions: HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias, Early Stage Lower Genital Tract Cancers. Basic parameters: from 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
Overview
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
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 2021-2027.
Interventions
- Diagnostic test Diagnostic tests for anal cancer screening
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.
Primary outcome measures
- Sensitivity and specificity of anal cytology [Time frame: Baseline]
Secondary outcome measures (12)
- Concordance of self- and clinician-collected PCR testing [Time frame: baseline]
- Prevalence of hrHPV types at baseline [Time frame: Baseline]
- hrHPV with Cobas PCR testing (self-collected) [Time frame: Baseline]
- hrHPV with Cobas PCR testing (self-collected) [Time frame: 12 months]
- hrHPV with Cobas PCR testing (self-collected) [Time frame: 24 months]
- hrHPV with Cobas PCR testing (clinician-collected) [Time frame: Baseline]
- hrHPV with Cobas PCR testing (clinician-collected) [Time frame: 12 months]
- hrHPV with Cobas PCR testing (clinician-collected) [Time frame: 24 months]
- Prevalence of aHSIL at baseline [Time frame: Baseline]
- Incidence of aHSIL at follow-up [Time frame: 24 months]
- Screening Experience Survey [Time frame: Baseline]
- Incidence of hrHPV, by type [Time frame: 12 months]
Eligibility criteria
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
Exclusion criteria
- prior history or high resolution anoscopy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 3 centers
- Icahn School of Medicine at Mount Sinai — New York
- Medical University of South Carolina — Charleston
- University of Texas M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05217940 · GCO 20-0309