Anal Canal HPV Infection Diagnosis, Anal Cancer, Anal Dysplasia Diagnosis
Conditions
Keywords
Anal HPV, Anal Dysplasia, Ana Cancer
Brief summary
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.
Interventions
DEVICEHC2 collection kit with a swab or brush
We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior
Sponsors
QIAGEN Gaithersburg, Inc
Laser Surgery Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HC2 can accurately test for oncogenic HPV in anal specimens | in approximately 12 months | Determination that HC2 testing in the anal canal can be performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of cytology with HC2 | in approximately 12 months | To determine if HC2 improves the sensitivity and specificity of anal cytology |
Countries
United States
Outcome results
None listed