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

Phase 0
Open (Enrolling)
Cervical Cancer Squamous Cell, Human Papilloma Virus Infection, Human Papilloma Virus-Related Carcinoma, Prevention

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Trial Information

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

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

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

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.

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

HR-HPV presence in the studied population.

Outcome Time Frame:

Up to 24 months

Safety Issue:


Principal Investigator

Adriana T Lorenzi, MSc

Investigator Role:

Principal Investigator


Brazil: Ethics Committee

Study ID:




Start Date:

March 2012

Completion Date:

February 2014

Related Keywords:

  • Cervical Cancer Squamous Cell
  • Human Papilloma Virus Infection
  • Human Papilloma Virus-Related Carcinoma
  • Prevention
  • Cervical Cancer
  • HPV
  • Secondary prevention
  • Carcinoma
  • Uterine Cervical Neoplasms
  • Papilloma
  • Virus Diseases
  • Warts
  • Neoplasms, Squamous Cell
  • Papillomavirus Infections