NCT01104181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

9 months

First QC Date

March 25, 2010

Last Update Submit

June 21, 2011

Conditions

Anal Canal HPV Infection DiagnosisAnal Dysplasia DiagnosisAnal Cancer

Keywords

Anal HPVAnal DysplasiaAna Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sensitivity and specificity of cytology with HC2

    in approximately 12 months

Study Arms (1)

swab and brush or swab and swab

EXPERIMENTAL

we will determine which collection method is superior

Device: HC2 collection kit with a swab or brush

Interventions

HC2 collection kit with a swab or brushDEVICE

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

Also known as: Qiagen HC2 HPV High-Risk DNA Test
swab and brush or swab and swab

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female 18 years of age or older
  • screened for anal dysplasia, including MSM and women -

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laser Surgery Care, Inc.

New York, New York, 10011, United States

Location

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Officials

  • Stephen E Goldstone, MD

    Mount Sinai Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2010

First Posted

April 15, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

US(1)