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
  Purpose

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 Phase
Cervical Cancer Squamous Cell
Human Papilloma Virus Infection
Human Papilloma Virus-Related Carcinoma
Prevention
Phase 0

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: CareHPV - Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • HR-HPV presence in the studied population. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Cervical cell samples (cytology)


Enrollment: 5079
Study Start Date: March 2012
Study Completion Date: February 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539668

Locations
Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14.784-400
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784-400
Sponsors and Collaborators
Barretos Cancer Hospital
QIAGEN Gaithersburg, Inc
Investigators
Principal Investigator: Adriana T Lorenzi, MSc
Study Director: Adhemar Longatto-Filho, PhD Barretos Cancer Hospital
  More Information

No publications provided

Responsible Party: Adhemar Longatto-Filho, Coordinator, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01539668     History of Changes
Other Study ID Numbers: careHPV_2012
Study First Received: January 23, 2012
Last Updated: February 25, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Barretos Cancer Hospital:
Cervical Cancer
HPV
Secondary prevention

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Papilloma
Papillomavirus Infections
Uterine Cervical Neoplasms
Virus Diseases
DNA Virus Infections
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Tumor Virus Infections
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014