Clinical trial · Interventional
Screening Strategies Among High-risk Populations for Anal Cancer
NCT06628570CI-TRIAL-00123947recruitingN/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 the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-Related Anal Squamous Cell Carcinoma | Human Papillomavirus-Related Anal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anal Cytology | Diagnostic Test | — | UNRESOLVED |
| CINtec®PLUS | Diagnostic Test | — | UNRESOLVED |
| Genotyping of anal hrHPV infection | Diagnostic Test | — | UNRESOLVED |
| HRA + Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Men with impaired immune status
- description
- At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
- interventionNames
- Diagnostic Test: HRA + Biopsy
- Diagnostic Test: Anal Cytology
- Diagnostic Test: Genotyping of anal hrHPV infection
- Diagnostic Test: CINtec®PLUS
- type
- OTHER
- label
- Men without impaired immune status
- description
- At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
- interventionNames
- Diagnostic Test: HRA + Biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 30-80 years of age * Individuals with chronic impaired immune status * History of lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2 Exclusion Criteria: * Patients treated for aHSIL less than 6 months before screening * History of anal cancer and pregnant women.
References
Publications (0)
Data not yet available
No reference posted for this study.