Early Stage Lower Genital Tract Cancers, HPV-related Anal Neoplasias, HPV-related Lower Genital Tract Neoplasias
Conditions
Keywords
anal cancer, anal precancerous, anal high grade intraepithelial lesion, anal cytology, high resolution anoscopy, anal human papilloma virus testing
Brief summary
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_TESTDiagnostic 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.
Sponsors
M.D. Anderson Cancer Center
Medical University of South Carolina
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of anal cytology | Baseline | Test sensitivity and specificity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of hrHPV types at baseline | Baseline | Proportion of subjects with high-risk HPV and subtype proportions |
| hrHPV with Cobas PCR testing (self-collected) | Baseline | Presence of high-risk HPV subtype |
| hrHPV with Cobas PCR testing (clinician-collected) | Baseline | Presence of high-risk HPV subtype |
| Prevalence of aHSIL at baseline | Baseline | Proportion of subjects with aHSIL |
| Concordance of self- and clinician-collected PCR testing | baseline | Proportionate concordance of high-risk HPV testing |
| Screening Experience Survey | Baseline | 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. |
| Incidence of hrHPV, by type | 12 months | Proportion of subjects with new hrHPV infection |
| Proportion of subjects with new hrHPV infection | 12 months | Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up |
| Incidence of aHSIL at follow-up | 24 months | Proportion of subjects with new aHSIL during follow-up period |
Countries
United States
Contacts
Primary ContactDaniela Solis
Outcome results
None listed