Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Ana... | NCT01104181

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

NCT01104181

Sponsor

Laser Surgery Care

Status

Completed

Last Update Posted

Jun 22, 2011Estimated

Enrollment

300Actual

Phase

Not Applicable

Conditions

Anal Canal HPV Infection Diagnosis
Anal Dysplasia Diagnosis
Anal Cancer

Interventions

HC2 collection kit with a swab or brush

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Mar 2011Actual

First Submitted Date

Mar 25, 2010

First Submission Date that Met QC Criteria

Apr 14, 2010

First Posted Date

Apr 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2011

Last Update Posted Date

Jun 22, 2011Estimated

Name	Class
QIAGEN Gaithersburg, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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	swab and brush or swab and swab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Sensitivity and specificity of cytology with HC2	To determine if HC2 improves the sensitivity and specificity of anal cytology	in approximately 12 months

Other Outcomes

Not provided

Eligibility Module

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. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen E Goldstone, MD	Mount Sinai Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laser Surgery Care, Inc.		New York	New York	10011	United States

Type	Date	Date Unknown
Release	Mar 17, 2014
Reset	Apr 18, 2014
Release	Sep 10, 2014
Reset	Sep 17, 2014

Submission Tracking

Estimated Results First Submitted Date

Mar 17, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 17, 2014			Apr 18, 2014
Sep 10, 2014

Condition Browse Module

MeSH Terms

ID	Term
D001005	Anus Neoplasms

Ancestor Terms

ID	Term
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014099	Toothbrushing

Ancestor Terms

ID	Term
D009910	Oral Hygiene
D011313	Preventive Dentistry
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided