Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas
NCT ID: NCT01539668
Last Updated: 2014-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5079 participants
OBSERVATIONAL
2012-03-31
2014-02-28
Brief Summary
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1\. Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer Hospital to evaluate their performance;
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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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QIAGEN Gaithersburg, Inc
INDUSTRY
Barretos Cancer Hospital
OTHER
Responsible Party
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Adhemar Longatto-Filho
Coordinator
Principal Investigators
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Adriana T Lorenzi, MSc
Role: PRINCIPAL_INVESTIGATOR
Adhemar Longatto-Filho, PhD
Role: STUDY_DIRECTOR
Barretos Cancer Hospital
Locations
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Barretos Cancer Hospital
Barretos, São Paulo, Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil
Countries
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Other Identifiers
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careHPV_2012
Identifier Type: -
Identifier Source: org_study_id
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