NCT01539668

Brief Summary

This study evaluates the women cervical samples through molecular tests in order to: 1\. Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer Hospital to evaluate their performance;

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,079

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

9 months

First QC Date

January 23, 2012

Last Update Submit

February 25, 2014

Conditions

Cervical Cancer Squamous CellHuman Papilloma Virus InfectionHuman Papilloma Virus-Related CarcinomaPrevention

Keywords

Cervical CancerHPVSecondary prevention

Outcome Measures

Primary Outcomes (1)

  • HR-HPV presence in the studied population.

    Up to 24 months

Secondary Outcomes (1)

  • The meaning of HPV presence relating with the conventional screening test (Papanicolaou smear), and the pattern of setting cervical lesion (biopsy).

    Up to 12 months

Study Arms (1)

Pap sampling

Women who have undergone Pap sampling and HPV and cytology analysis. The samples will be collected in Mobile Units and Non-Mobile Units.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undegone Pap sampling in a Mobile Unit and Non-Mobile Units.

You may qualify if:

  • Any women who come to do the Papanicolaou test at the Barretos Cancer Hospital and in the mobile units on the remote Brazilian areas.

You may not qualify if:

  • not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Barretos Cancer Hospital

Barretos, São Paulo, 14.784-400, Brazil

Location

Barretos Cancer Hospital

Barretos, São Paulo, 14784-400, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cervical cell samples (cytology)

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Adriana T Lorenzi, MSc

    PRINCIPAL INVESTIGATOR

  • Adhemar Longatto-Filho, PhD

    Barretos Cancer Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator

Study Record Dates

First Submitted

January 23, 2012

First Posted

February 27, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

February 1, 2014

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

BR(2)