Clinical trial NCT01539668: Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas
Official title: CareHPV - Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer Squamous Cell
Human Papilloma Virus Infection
Human Papilloma Virus-Related Carcinoma
Prevention
Keywords: Cervical Cancer
HPV
Secondary prevention
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
Collaborators: name: QIAGEN Gaithersburg, Inc
First posted: 2012-02-27
Enrollment: 5079
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undegone Pap sampling in a Mobile Unit and Non-Mobile Units.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HR-HPV presence in the studied population.
timeFrame: Up to 24 months
Secondary outcomes:
measure: The meaning of HPV presence relating with the conventional screening test (Papanicolaou smear), and the pattern of setting cervical lesion (biopsy).
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
Study officials:
name: Adriana T Lorenzi, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Barretos Cancer Hospital
name: Adhemar Longatto-Filho, PhD
role: STUDY_DIRECTOR
References: