HPV-related Lower Genital Tract NeoplasiasSWANNCT05217940
Screening Women With Prior HPV for Anal Neoplasia
A study testing Diagnostic tests for anal cancer screening in people with HPV-related Lower Genital Tract Neoplasias and HPV-related Anal Neoplasias, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias, Early Stage Lower Genital Tract Cancers
- What is being tested?
- Diagnostic tests for anal cancer screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Mar 2022to Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- prior history or high resolution anoscopy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Talia Wahl, wahlt@musc.edu
Ashish Deshmukh, PhD
- Recruiting
University of Texas M D Anderson Cancer Center
Houston, Texas, 77030
Elizabeth Chiao, EYChiao@mdanderson.org
Elizabeth Chiao, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Daniela Solis, 305-775-2140, daniela.solis@mountsinai.org
Keith Sigel, MD PHD MPH
About this study
Official title: The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
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.
Read the 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.
- Conditions
- HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias, Early Stage Lower Genital Tract Cancers
- Being tested
- Diagnostic tests for anal cancer screening
- Keywords
- anal cancer, anal precancerous, anal high grade intraepithelial lesion, anal cytology, high resolution anoscopy, anal human papilloma virus testing
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic tests for anal cancer screeningDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Women With Prior HPV for Anal Neoplasia | Experimental | Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy. Receives: Diagnostic Test: Diagnostic tests for anal cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of anal cytology
Test sensitivity and specificity
Measured: Baseline
Secondary outcomes (15)
Concordance of self- and clinician-collected PCR testing
Proportionate concordance of high-risk HPV testing
Measured: baseline
Prevalence of hrHPV types at baseline
Proportion of subjects with high-risk HPV and subtype proportions
Measured: Baseline
hrHPV with Cobas PCR testing (self-collected)
Presence of high-risk HPV subtype
Measured: Baseline
hrHPV with Cobas PCR testing (self-collected)
Presence of high-risk HPV subtype
Measured: 12 months
hrHPV with Cobas PCR testing (self-collected)
Presence of high-risk HPV subtype
Measured: 24 months
hrHPV with Cobas PCR testing (clinician-collected)
Presence of high-risk HPV subtype
Measured: Baseline
hrHPV with Cobas PCR testing (clinician-collected)
Presence of high-risk HPV subtype
Measured: 12 months
hrHPV with Cobas PCR testing (clinician-collected)
Presence of high-risk HPV subtype
Measured: 24 months
Prevalence of aHSIL at baseline
Proportion of subjects with aHSIL
Measured: Baseline
Incidence of aHSIL at follow-up
Proportion of subjects with new aHSIL during follow-up period
Measured: 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.
Measured: Baseline
Incidence of hrHPV, by type
Proportion of subjects with new hrHPV infection
Measured: 12 months
Incidence of hrHPV, by type
Proportion of subjects with new hrHPV infection
Measured: 24 months
Proportion of subjects with new hrHPV infection
Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up
Measured: 12 months
Proportion of subjects with new hrHPV infection
Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start2 Mar 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-related Lower Genital Tract NeoplasiasStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Medical University of South Carolina
- Responsible party
- Principal investigator, Keith M Sigel, Icahn School of Medicine at Mount Sinai
- Investigators
- Keith Sigel, MD, PhD, MPH, Principal investigator, Icahn School of Medicine at Mount SinaiElizabeth Chiao, MD, Principal investigator, M.D. Anderson Cancer CenterAshish Deshmukh, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217940
- Sponsor's protocol ID
- GCO 20-0309
- Acronym
- SWAN
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.