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Effectiveness of Screening Women with Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
Trial Status: active
This clinical trial explores how common abnormal precancer anal lesions and anal cancer are in people assigned female gender at birth (AFAB) with precancerous lesions (neoplasia) in their other genital organs. Anal cancer, like most cervical cancers, is caused by human papillomavirus (HPV) infection and is one of the fastest accelerating causes of cancer incidence and mortality among all cancer sites. Screening for anal cancer can help identify precancerous lesions so they can be treated to prevent progression to cancer. Being able to determine how well screening tests that are typically used to diagnose anal precancers work in women, trans men, and other AFAB individuals at risk of these lesions may help assess whether these tests are acceptable for patients. This study will evaluate whether a specimen self-collection for HPV testing is an acceptable test for patients.
Inclusion Criteria
Women with a history of pathologically proven high-grade genital HPV associated neoplastic disease (cervical squamous intraepithelial neoplasia 2 [CIN2+], vulvar squamous intraepithelial lesion [VIN2+], or vaginal intraepithelial neoplasia (VaIN) 2+, or history of non-metastatic cervical, vaginal or vulvar cancer
No known history of human immunodeficiency virus (HIV) infection
No history of high resolution anoscopy (HRA)
Aged >= 35 years
Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston who are English or Spanish speaking
Exclusion Criteria
Those with platelet counts < 75,000 cells/mm^3
Irreversible bleeding disorder, or any illness that, in the opinion of the investigator, would contraindicate any biopsy of the anal canal
Prior anal cancer precursor testing (e.g. high resolution anoscopy) or current diagnosis or history of anal cancer
Additional locations may be listed on ClinicalTrials.gov for NCT05217940.
Ia. To evaluate the respective screening test characteristics of anal cytology, clinician-collected and self collected high-risk HPV (hrHPV) testing, and cytology/hrHPV cotesting compared to the gold standard of high resolution anoscopy (HRA) exam with biopsy.
Ib. To determine baseline anal hrHPV and histologic anal high-grade squamous intraepithelial lesions (haHSIL) prevalence and longitudinal risk among women with lower genital tract neoplasia (WLGTN).
II. To compare patient acceptability and experiences for anal cancer screening strategies among WLGTN.
III. To develop a mathematical model determining the potential mortality and morbidity benefits, harms, and cost-effectiveness of anal dysplasia screening and/or hrHPV testing in WLGTN.
OUTLINE:
Patients undergo external anogenital exam, digital anorectal exam, anal cytology testing, anal and vaginal HPV swabs (clinician- and self-collected), and HRA with biopsy of any lesions on trial. Patients also undergo blood and saliva specimen collection on trial.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationIcahn School of Medicine at Mount Sinai
