Clinical trial · Interventional
Screening Women With Prior HPV for Anal Neoplasia
The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
NCT05217940CI-TRIAL-00094023SWANrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Lower Genital Tract Cancers | — | UNRESOLVED | — |
| HPV-related Anal Neoplasias | — | UNRESOLVED | — |
| HPV-related Lower Genital Tract Neoplasias | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic tests for anal cancer screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women With Prior HPV for Anal Neoplasia
- description
- Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.
- interventionNames
- Diagnostic Test: Diagnostic tests for anal cancer screening
Primary outcomes (1)
- measure
- Sensitivity and specificity of anal cytology
- timeFrame
- Baseline
- description
- Test sensitivity and specificity
Secondary outcomes (15)
- measure
- Concordance of self- and clinician-collected PCR testing
- timeFrame
- baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.