Cervical Cancer Squamous CellcareHPVNCT01539668
Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas
An observational study of Cervical Cancer Squamous Cell and Human Papilloma Virus Infection, run by Barretos Cancer Hospital at 2 sites in Brazil.
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; Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Squamous Cell, Human Papilloma Virus Infection, Human Papilloma Virus-Related Carcinoma
- How many people
- 5,079 participants
- Where
- 2 sitesBrazil
- Study dates
- Mar 2012to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who have undegone Pap sampling in a Mobile Unit and Non-Mobile Units.
Who may be able to join
- Any women who come to do the Papanicolaou test at the Barretos Cancer Hospital and in the mobile units on the remote Brazilian areas.
Who cannot join
- not applicable.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Barretos Cancer Hospital
Barretos, São Paulo, 14.784-400
Barretos Cancer Hospital
Barretos, São Paulo, 14784-400
About this study
Official title: 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:
- Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer Hospital to evaluate their performance;
Read the 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.
- Conditions
- Cervical Cancer Squamous Cell, Human Papilloma Virus Infection, Human Papilloma Virus-Related Carcinoma, Prevention
- Keywords
- Cervical Cancer, HPV, Secondary prevention
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HR-HPV presence in the studied population.
Measured: Up to 24 months
Secondary outcomes (1)
The meaning of HPV presence relating with the conventional screening test (Papanicolaou smear), and the pattern of setting cervical lesion (biopsy).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Squamous CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- QIAGEN Gaithersburg, Inc
- Responsible party
- Principal investigator, Adhemar Longatto-Filho, Barretos Cancer Hospital
- Investigators
- Adriana T Lorenzi, MSc, Principal investigatorAdhemar Longatto-Filho, PhD, Study director, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539668
- Sponsor's protocol ID
- careHPV_2012
- Acronym
- careHPV
- Status last verified
- Feb 2014
- First submitted
- 23 Jan 2012
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CareHPV - Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas
- ClinicalTrials.gov ID
- NCT01539668
- Acronym / sponsor ID
- careHPV / careHPV_2012
- Conditions
- Cervical Cancer Squamous Cell, Human Papilloma Virus Infection, Human Papilloma Virus-Related Carcinoma, Prevention
- Keywords
- Cervical Cancer, HPV, Secondary prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,079 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Collaborators
- QIAGEN Gaithersburg, Inc
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the women cervical samples through molecular tests in order to:
- 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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undegone Pap sampling in a Mobile Unit and Non-Mobile Units.
Key inclusion criteria (1 listed)
- Any women who come to do the Papanicolaou test at the Barretos Cancer Hospital and in the mobile units on the remote Brazilian areas.
Key exclusion criteria (1 listed)
- not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HR-HPV presence in the studied population.
Time frame: Up to 24 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana T Lorenzi, MSc principal investigator
Adhemar Longatto-Filho, PhD study director
Barretos Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Squamous Cell and Human Papilloma Virus Infection, run by Barretos Cancer Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HR-HPV presence in the studied population. (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.