Infections

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Virus Diseases

Papilloma

Anus Neoplasms

Anal Cancer

Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.

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.

Diagnostic tests for anal cancer screening

Daniela Solis

Nadia M Zubair, MPH

Keith Sigel, MD PHD MPH

Ashish Deshmukh, PhD

Elizabeth Chiao

Elizabeth Chiao, MD

Keith Sigel, MD, PhD, MPH

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.

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.

Screening Women With Prior HPV for Anal Neoplasia

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

All of the individual participant data collected during the trial, after deidentification.

Proportionate concordance of high-risk HPV testing

Proportion of subjects with high-risk HPV and subtype proportions

Proportion of subjects with new aHSIL during follow-up period

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.

Proportion of subjects with new hrHPV infection

Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Screening Women With Prior HPV for Anal Neoplasia	NCT05217940	HPV-related Low... HPV-related Ana... Early Stage Low...	Diagnostic test...	35 Years -	Icahn School of Medicine at Mount Sinai
Screening Women With Prior HPV for Anal Neoplasia	NCT05217940	HPV-related Low... HPV-related Ana... Early Stage Low...	Diagnostic test...	35 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for anal high grade intraepithelial lesion