Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas (careHPV)
|ClinicalTrials.gov Identifier: NCT01539668|
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : February 26, 2014
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;
|Condition or disease||Phase|
|Cervical Cancer Squamous Cell Human Papilloma Virus Infection Human Papilloma Virus-Related Carcinoma Prevention||Early Phase 1|
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.
|Study Type :||Observational|
|Actual Enrollment :||5079 participants|
|Official Title:||CareHPV - Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas|
|Study Start Date :||March 2012|
|Primary Completion Date :||December 2012|
|Study Completion Date :||February 2014|
Women who have undergone Pap sampling and HPV and cytology analysis. The samples will be collected in Mobile Units and Non-Mobile Units.
- HR-HPV presence in the studied population. [ Time Frame: Up to 24 months ]
- The meaning of HPV presence relating with the conventional screening test (Papanicolaou smear), and the pattern of setting cervical lesion (biopsy). [ Time Frame: Up to 12 months ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539668
|Barretos Cancer Hospital|
|Barretos, São Paulo, Brazil, 14.784-400|
|Barretos Cancer Hospital|
|Barretos, São Paulo, Brazil, 14784-400|
|Principal Investigator:||Adriana T Lorenzi, MSc|
|Study Director:||Adhemar Longatto-Filho, PhD||Barretos Cancer Hospital|