An interventional study of Diagnostic tests for anal cancer screening in HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias and Early Stage Lower Genital Tract Cancers, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 3 sites in United States. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Screening
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 2021-2027.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 300 is above the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.
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.
Sensitivity and specificity of anal cytology
Test sensitivity and specificity
Time frame: Baseline
Concordance of self- and clinician-collected PCR testing
Proportionate concordance of high-risk HPV testing
Time frame: baseline
Prevalence of hrHPV types at baseline
Proportion of subjects with high-risk HPV and subtype proportions
Time frame: Baseline
hrHPV with Cobas PCR testing (self-collected)
Presence of high-risk HPV subtype
Time frame: Baseline
hrHPV with Cobas PCR testing (self-collected)
Presence of high-risk HPV subtype
Time frame: 12 months
hrHPV with Cobas PCR testing (self-collected)
Presence of high-risk HPV subtype
Time frame: 24 months
hrHPV with Cobas PCR testing (clinician-collected)
Presence of high-risk HPV subtype
Time frame: Baseline
hrHPV with Cobas PCR testing (clinician-collected)
Presence of high-risk HPV subtype
Time frame: 12 months
hrHPV with Cobas PCR testing (clinician-collected)
Presence of high-risk HPV subtype
Time frame: 24 months
Prevalence of aHSIL at baseline
Proportion of subjects with aHSIL
Time frame: Baseline
Incidence of aHSIL at follow-up
Proportion of subjects with new aHSIL during follow-up period
Time frame: 24 months
Screening Experience Survey
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.
Time frame: Baseline
Incidence of hrHPV, by type
Proportion of subjects with new hrHPV infection
Time frame: 12 months
Incidence of hrHPV, by type
Proportion of subjects with new hrHPV infection
Time frame: 24 months
Proportion of subjects with new hrHPV infection
Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up
Time frame: 12 months
Proportion of subjects with new hrHPV infection
Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up
Time frame: 24 months
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol
Time frame: Beginning 3 months and ending 5 years following article publication.
Access criteria: Researchers who provide a methodologically sound proposal. Any purpose. Email principal investigator: keith.sigel@mssm.edu
No publications or documents are linked to this record.
Started Mar 2022 (actual). Primary completion is estimated for Jan 2027, 58 months after the start.
Of 39 interventional studies with no phase under Anus Neoplasms, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 17. This study's planned 58 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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