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OpenTrials
Completed

NCT Number: NCT01104181

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

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.

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Key information

Conditions

Anal Canal HPV Infection Diagnosis Anal Cancer Anal Dysplasia Diagnosis Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laser Surgery Care, Inc.

New York, 10011, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

HC2 collection kit with a swab or brush

Device

We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior

Other names: Qiagen HC2 HPV High-Risk DNA Test

Primary outcomes

  1. HC2 can accurately test for oncogenic HPV in anal specimens

    Time frame: in approximately 12 months

    Determination that HC2 testing in the anal canal can be performed

Secondary outcomes

  1. Sensitivity and specificity of cytology with HC2

    Time frame: in approximately 12 months

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

Sponsors and collaborators

Lead sponsor

Laser Surgery Care

Other

Collaborators

  • QIAGEN Gaithersburg, Inc

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Apr 15, 2010
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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