Female Urine, Vaginal & Endocervical Swab & Cervical Spec... | NCT01427023

Status Module

Record Verification Date

Feb 2014

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

Aug 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 26, 2011

First Submission Date that Met QC Criteria

Aug 30, 2011

First Posted Date

Sep 1, 2011Estimated

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

Feb 5, 2014

Last Update Posted Date

Feb 6, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay.

These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

532Actual

Name	Type	Description	Arm Group Labels	Other Names
APTIMA Trichomonas vaginalis (ATV) Assay	Device	APTIMA Trichomonas vaginalis (ATV) Assay

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.	Positive Percent Agreement Using the TIGRIS Instrument as a Reference.	approximately one year
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.	Negative Percent Agreement Using the TIGRIS Instrument as a Reference.	approximately one year

Secondary Outcomes

Measure	Description	Time Frame
Positivity Rate	Positivity Rate	approximately one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be female and attend a participating clinic
Subject must be at least 14 years of age at the time of enrollment and is currently sexually active (has had vaginal intercourse within the past 12 months)
The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of her parent or legal guardian, unless the site has an institutional review board (IRB)- approved waiver for parental consent for minors)
In addition, the subject must meet at least one of the following criteria:
- Subject must demonstrate symptoms consistent with a suspected STD such as vaginal odor, vaginal discharge, vaginal/vulvar itching or irritation, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
- Subject must be asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STD(s)
- Subject must be asymptomatic and undergoing screening evaluation for possible STDs
- Subject must be undergoing Pap screening

Exclusion Criteria:

Subject took antibiotic medications within the last 14 days
Subject already participated in the study
Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama, Birmingham		Birmingham	Alabama	35294	United States
Wishard Hospital - Indiana University School of Medicine

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections