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

This study has been completed.
Sponsor:
Collaborator:
QIAGEN Gaithersburg, Inc
Information provided by (Responsible Party):
Adhemar Longatto-Filho, Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01539668
First received: January 23, 2012
Last updated: February 25, 2014
Last verified: February 2014

January 23, 2012
February 25, 2014
March 2012
December 2012   (final data collection date for primary outcome measure)
HR-HPV presence in the studied population. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01539668 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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;

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cervical cell samples (cytology)

Non-Probability Sample

Patients who have undegone Pap sampling in a Mobile Unit and Non-Mobile Units.

  • Cervical Cancer Squamous Cell
  • Human Papilloma Virus Infection
  • Human Papilloma Virus-Related Carcinoma
  • Prevention
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5079
February 2014
December 2012   (final data collection date for primary outcome measure)

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.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01539668
careHPV_2012
No
Adhemar Longatto-Filho, Barretos Cancer Hospital
Barretos Cancer Hospital
QIAGEN Gaithersburg, Inc
Principal Investigator: Adriana T Lorenzi, MSc
Study Director: Adhemar Longatto-Filho, PhD Barretos Cancer Hospital
Barretos Cancer Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP