Clinical trial · Interventional
Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test
Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)
NCT01104181CI-TRIAL-00005045completedN/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)
This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.
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 |
|---|---|---|---|
| Anal Canal HPV Infection Diagnosis | — | UNRESOLVED | — |
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Anal Dysplasia Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HC2 collection kit with a swab or brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- swab and brush or swab and swab
- description
- we will determine which collection method is superior
- interventionNames
- Device: HC2 collection kit with a swab or brush
Primary outcomes (1)
- measure
- HC2 can accurately test for oncogenic HPV in anal specimens
- timeFrame
- in approximately 12 months
- description
- Determination that HC2 testing in the anal canal can be performed
Secondary outcomes (1)
- measure
- Sensitivity and specificity of cytology with HC2
- timeFrame
- in approximately 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. male or female 18 years of age or older 2. screened for anal dysplasia, including MSM and women - Exclusion Criteria: 1. subject has had a previous treatment for anal cancer. 2. subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection. 3. subjects that have bleeding disorders or use anticoagulation treatments. -
References
Publications (0)
Data not yet available
No reference posted for this study.