Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas

CareHPV - Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01539668

Acronym

careHPV

Enrollment

5079

Registered

2012-02-27

Start date

2012-03-31

Completion date

2014-02-28

Last updated

2014-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer Squamous Cell, Human Papilloma Virus Infection, Human Papilloma Virus-Related Carcinoma, Prevention

Keywords

Cervical Cancer, HPV, Secondary prevention

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;

Detailed description

Step1: Ambulatory samples First of all the careHPV cervical sample will be collected in specifically tubes, after this, make the cervical sample SurePath collect. Each patient will have two cervical samples. In this moment will be collected 2,000 samples at the Gynecology Department of Barretos Cancer Hospital and the women who be attended in the mobile unit of Barretos surrounding. Sample1: careHPV The collect will be randomized where 1000 will be collected by the doctor and 1000 by self-sampling. The patient will be oriented by nurse with illustrative material. The self-sampling will be realized like the manufacturing protocol (Qiagen Inc., Gaithersburg, MD). The cervical sample to cytology (SurePath) will be realized by doctor like a complementary test. The conditions to store the samples are 15˚C to 30˚C by 2 weeks; 2˚C to 8˚C by 4 weeks; or -20˚C by 2 months to research. Sample2: SurePath® cytology The cervical sample will be realized like the manufacturing protocol, by doctor. The lamina will be prepared like the equipment manufactory (Becton, Dickinson and Company). The cytological findings will be classifieds like the Bethesda system. The positives women in careHPV/cytology and the negative careHPV but positive cytology (ASC-US+) will be referred to do the colposcopy (or biopsy) at the Barretos Cancer Hospital. Step2: Mobiles Unities Samples This step will be collected 3,000 samples to careHPV test and SurePath cytology like a complementary test. The self-sampling won't be made in this step. The samples will be analyzed in the own mobile unit, during the cities visited. The units involved in the project are that attended Mato Grosso, Goiás, Minas Gerais and Rondônia states, because the significantly number of population assisted. Step3: HPV genotyping All the positives cases to careHPV test will be submitted to identify the HPV types, then realized at the Molecular Oncology Research Center in the Barretos Cancer Hospital.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* not applicable.

Design outcomes

Primary

Measure	Time frame
HR-HPV presence in the studied population.	Up to 24 months

Secondary

Measure	Time frame
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

Countries

Brazil

Outcome results