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

NCT01104181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-06-22

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • QIAGEN Gaithersburg, Inc

    collaborator INDUSTRY

  • Laser Surgery Care

    lead OTHER

Principal Investigators

  • Stephen E Goldstone, MD · Mount Sinai Medical School

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01104181 on ClinicalTrials.gov