Cervix Cytological Screening - Comparison of Tampon Self-... | NCT00377845

Studies
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

NCT00377845

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Mar 27, 2008Estimated

Enrollment

100Estimated

Phase

Early Phase 1

Conditions

Uterine Cervical Dysplasia
Uterine Cervical Neoplasms

Interventions

Regular Tampax used in 3 hours

Countries

Denmark

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

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

Sep 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Mar 2008Actual

First Submitted Date

Sep 18, 2006

First Submission Date that Met QC Criteria

Sep 18, 2006

First Posted Date

Sep 19, 2006Estimated

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

Mar 26, 2008

Last Update Posted Date

Mar 27, 2008Estimated

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 purpose of this study is to compare suitability, specificity and sensitivity of the routine smear and the tampon self-test women perform at home.

Study hypothesis: The tampon self-test correspond to the routine cervical smear.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
Regular Tampax used in 3 hours	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of the tampon self-test

Secondary Outcomes

Measure	Description	Time Frame
The womens socio-demographic relations according to accept the tampon self-test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with cervical dysplasia been referred to conisation or
Women invited to cervical screening program

Exclusion Criteria:

Women not performing the tampon self-test before conisation or
Women not performing the tampon self-test af least 1 month after receiving the tampon

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Svanholm, consultant	Randers Hospital, Pathological Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Region Hospital Randers		Randers		8900	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D002578	Uterine Cervical Dysplasia
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases

Browse Leaves

Not provided

Browse Branches

Not provided