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NCT01539668 Clinical Trial

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

Prevention Clinical Trial

— careHPV  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01539668
Other study ID # careHPV_2012
Secondary ID
Status Completed
Phase Phase 0
First received January 23, 2012
Last updated February 25, 2014
Start date March 2012
Est. completion date February 2014

Study information
Verified date February 2014
Source Barretos Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial 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;

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.

Recruitment information / eligibility
Status Completed
Enrollment 5079
Est. completion date February 2014
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Barretos Cancer Hospital Barretos São Paulo
Brazil Barretos Cancer Hospital Barretos São Paulo

Sponsors (2)
Lead Sponsor Collaborator
Barretos Cancer Hospital QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary HR-HPV presence in the studied population. Up to 24 months No
Secondary The meaning of HPV presence relating with the conventional screening test (Papanicolaou smear), and the pattern of setting cervical lesion (biopsy). Up to 12 months No
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