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

Primary Purpose

Anal Canal HPV Infection Diagnosis, Anal Dysplasia Diagnosis, Anal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HC2 collection kit with a swab or brush
Sponsored by
Laser Surgery Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anal Canal HPV Infection Diagnosis focused on measuring Anal HPV, Anal Dysplasia, Ana Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Laser Surgery Care, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

swab and brush or swab and swab

Arm Description

we will determine which collection method is superior

Outcomes

Primary Outcome Measures

HC2 can accurately test for oncogenic HPV in anal specimens
Determination that HC2 testing in the anal canal can be performed

Secondary Outcome Measures

Sensitivity and specificity of cytology with HC2
To determine if HC2 improves the sensitivity and specificity of anal cytology

Full Information

First Posted
March 25, 2010
Last Updated
June 21, 2011
Sponsor
Laser Surgery Care
Collaborators
QIAGEN Gaithersburg, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01104181
Brief Title
Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test
Official Title
Collection of Anal Specimens for Assessment of Anal Cancer Using the HC2 High-Risk DNA Test (QIAGEN)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laser Surgery Care
Collaborators
QIAGEN Gaithersburg, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Canal HPV Infection Diagnosis, Anal Dysplasia Diagnosis, Anal Cancer
Keywords
Anal HPV, Anal Dysplasia, Ana Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
swab and brush or swab and swab
Arm Type
Experimental
Arm Description
we will determine which collection method is superior
Intervention Type
Device
Intervention Name(s)
HC2 collection kit with a swab or brush
Other Intervention Name(s)
Qiagen HC2 HPV High-Risk DNA Test
Intervention Description
We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior
Primary Outcome Measure Information:
Title
HC2 can accurately test for oncogenic HPV in anal specimens
Description
Determination that HC2 testing in the anal canal can be performed
Time Frame
in approximately 12 months
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of cytology with HC2
Description
To determine if HC2 improves the sensitivity and specificity of anal cytology
Time Frame
in approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male or female 18 years of age or older screened for anal dysplasia, including MSM and women - Exclusion Criteria: subject has had a previous treatment for anal cancer. subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection. subjects that have bleeding disorders or use anticoagulation treatments. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen E Goldstone, MD
Organizational Affiliation
Mount Sinai Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser Surgery Care, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

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

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