Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test

Anal Cancer Clinical Trial

Official title:

Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104181
• Other study ID #: R09-HPV-001
• Status: Completed
• Phase: N/A
• First received: March 25, 2010
• Last updated: June 21, 2011
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Laser Surgery Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Anal Canal HPV Infection Diagnosis
• Anal Cancer
• Anal Dysplasia Diagnosis
• Anus Neoplasms

Intervention

Device:
• HC2 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

Locations

Country	Name	City	State
United States	Laser Surgery Care, Inc.	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Laser Surgery Care	QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HC2 can accurately test for oncogenic HPV in anal specimens	Determination that HC2 testing in the anal canal can be performed	in approximately 12 months
Secondary	Sensitivity and specificity of cytology with HC2	To determine if HC2 improves the sensitivity and specificity of anal cytology	in approximately 12 months