Clinical trial NCT05217940: Screening Women With Prior HPV for Anal Neoplasia
Official title: The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV-related Lower Genital Tract Neoplasias
HPV-related Anal Neoplasias
Early Stage Lower Genital Tract Cancers
Keywords: anal cancer
anal precancerous
anal high grade intraepithelial lesion
anal cytology
high resolution anoscopy
anal human papilloma virus testing
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Medical University of South Carolina
First posted: 2022-02-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Sensitivity and specificity of anal cytology
timeFrame: Baseline
Secondary outcomes:
measure: Concordance of self- and clinician-collected PCR testing
timeFrame: baseline
measure: Prevalence of hrHPV types at baseline
timeFrame: Baseline
measure: hrHPV with Cobas PCR testing (self-collected)
timeFrame: Baseline
measure: hrHPV with Cobas PCR testing (self-collected)
timeFrame: 12 months
measure: hrHPV with Cobas PCR testing (self-collected)
timeFrame: 24 months
measure: hrHPV with Cobas PCR testing (clinician-collected)
timeFrame: Baseline
measure: hrHPV with Cobas PCR testing (clinician-collected)
timeFrame: 12 months
measure: hrHPV with Cobas PCR testing (clinician-collected)
timeFrame: 24 months
measure: Prevalence of aHSIL at baseline
timeFrame: Baseline
measure: Incidence of aHSIL at follow-up
timeFrame: 24 months
measure: Screening Experience Survey
timeFrame: Baseline
measure: Incidence of hrHPV, by type
timeFrame: 12 months
measure: Incidence of hrHPV, by type
timeFrame: 24 months
measure: Proportion of subjects with new hrHPV infection
timeFrame: 12 months
measure: Proportion of subjects with new hrHPV infection
timeFrame: 24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Keith Sigel, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Elizabeth Chiao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Ashish Deshmukh, PhD
role: PRINCIPAL_INVESTIGATOR
References: