HPV Screening (Human Papilloma Virus) | NCT02613611

Studies
HPV Screening (Human Papilloma Virus)

NCT02613611

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Nov 24, 2015Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

HPV Testing

Interventions

Not provided

Countries

Not provided

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

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Nov 21, 2015

First Submission Date that Met QC Criteria

Nov 21, 2015

First Posted Date

Nov 24, 2015Estimated

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

Nov 21, 2015

Last Update Posted Date

Nov 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

suzy abdelaziz Abdelhamid, lecturer of obgyn., Kasr El Aini HospitalPrincipal Investigator

Lead Sponsor

Kasr El Aini HospitalOTHER

Collaborators

Not provided

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

Examination of cervical &urine samples for HPV

Detailed Description

500 females attending colposcopy kasrelaini unit are included. History including age and parity is taken.urine samples are taken. Colposcopy will be done. Pap smear will be taken and sent for pathology.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with positive urine test for HPV Number of patients with positive pap smear.		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all females attending colposcopy kasrelaini unit aging 18_45 years

Exclusion Criteria:

females with known cervical cancer
females less than 18 or more than 45

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

500 females attending colposcopy kasrelaini unit aging 18_45 years

Sampling Method

Probability Sample