Expression of Oncogenic Human Papillomavirus E6/E7 Protei... | NCT00526370

Studies
Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

NCT00526370

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Aug 13, 2008Estimated

Enrollment

72Actual

Phase

Not provided

Conditions

Normal Uterine Cervical Cytology
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms

Interventions

Not provided

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

Aug 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

Aug 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Sep 6, 2007

First Submission Date that Met QC Criteria

Sep 6, 2007

First Posted Date

Sep 10, 2007Estimated

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

Aug 12, 2008

Last Update Posted Date

Aug 13, 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 examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses.

Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Women with at least moderate dysplasia in biopsies from cervix uteri
B		Women with only normal PAP-smears

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of the HPV test of the material from the tampon self-test		Spring 2008

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with cervical dysplasia been referred to conisation.
Women invited to cervical screening program and with only normal smear and normal smears in their history.

Exclusion Criteria:

Women not performing the tampon self-test before conisation.
Women not performing the tampon self-test at least 3 month after having a normal PAP-smear taken.

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

50 women in out-patient gynecological ward in account of cervical cell changes and 50 women in the national screening program for cervical cancer, included by their G.P.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Svanholm, Head of department	Region Hospital, Department of Pathology	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