Cervical Cancer Cin GradeNMDSS2NCT01647724
New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening
An observational study of Cervical Cancer Cin Grade, run by Azienda Sanitaria Locale 4, Teramo at 1 site in Italy.
Trial summary
The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. Read more about this study
- Who is it for?
- Ages 35 to 64 years, women only
- Conditions the study is for
- Cervical Cancer Cin Grade
- How many people
- 15,000 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Mar 2013
- 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 35 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
Who may be able to join
- All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall
Who cannot join
- does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site
AUSL4 Teramo
Teramo, TE, 64100
Emma Altobelli, Prof., 0861420280 ext. +39, amedeo.lattanzi@aslteramo.it
Emma Altobelli, Prof.
About this study
Official title: Experimentation of New Organizational Models of Cervical Cancer Screening Programs, Upon the Use of HPV Test as First Level: Evaluation of the Methodologies Proposed of the Use of Self-sampling Devices to Recover Non-responders.
The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. It allows for privacy, reduces discomfort and women know nobody would have to handle their body.
Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.
Read the detailed description
In a previous trial (ISRCTN96071600) the investigators tested on 2400 women, compliance with self sampler device (PantaRhei Devices, Zeist, the Netherlands).
With this study the investigators analyze the response to two channels of transmission of the device (a model of device easier, and less expensive than the previous), such as screening for colon cancer.
The shipment of the device at home and taking on a local pharmacy. Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
- Conditions
- Cervical Cancer Cin Grade
- Keywords
- cervical cancer, prevention, screening
- Medical subject headings
- 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 |
|---|---|---|
| control 1 | standard recall letter to perform HPV test at the clinic | |
| Intervention 1 | direct mailing of the self sampling device at home | |
| intervention 2 | invitation to retire the self sampling device in local pharmacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
performing a HPV test within 3 months since the recall letter
Measured: up to december 2012 (up to 3 months)
Secondary outcomes (1)
How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before)
Measured: up to december 2012 (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer Cin GradeStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale 4, Teramo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Altobelli, Azienda Sanitaria Locale 4, Teramo
- Investigators
- Emma Altobelli, Prof., Study director, AUSL4 Teramo - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647724
- Sponsor's protocol ID
- NMD2TE
- Acronym
- NMDSS2
- Status last verified
- May 2012
- First submitted
- 17 Jul 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Giorgi Rossi P, Fortunato C, Barbarino P, Boveri S, Caroli S, Del Mistro A, Ferro A, Giammaria C, Manfredi M, Moretto T, Pasquini A, Sideri M, Tufi MC, Cogo C, Altobelli E; HPV Self-sampling Italian Working Group. Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter. Br J Cancer. 2015 Feb 17;112(4):667-75. doi: 10.1038/bjc.2015.11. Epub 2015 Jan 29.
PubMed 25633037
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimentation of New Organizational Models of Cervical Cancer Screening Programs, Upon the Use of HPV Test as First Level: Evaluation of the Methodologies Proposed of the Use of Self-sampling Devices to Recover Non-responders.
- ClinicalTrials.gov ID
- NCT01647724
- Acronym / sponsor ID
- NMDSS2 / NMD2TE
- Conditions
- Cervical Cancer Cin Grade
- Keywords
- cervical cancer, prevention, screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale 4, TeramoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 24 Jul 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.
The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. It allows for privacy, reduces discomfort and women know nobody would have to handle their body.
Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.
Detailed description
In a previous trial (ISRCTN96071600) the investigators tested on 2400 women, compliance with self sampler device (PantaRhei Devices, Zeist, the Netherlands).
With this study the investigators analyze the response to two channels of transmission of the device (a model of device easier, and less expensive than the previous), such as screening for colon cancer.
The shipment of the device at home and taking on a local pharmacy. Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control 1 | – | –standard recall letter to perform HPV test at the clinic |
| Intervention 1 | – | –direct mailing of the self sampling device at home |
| intervention 2 | – | –invitation to retire the self sampling device in local pharmacy |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
Key inclusion criteria (1 listed)
- All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall
Key exclusion criteria (1 listed)
- does not meet inclusion criteria
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
performing a HPV test within 3 months since the recall letter
Time frame: up to december 2012 (up to 3 months)
1 secondary outcome
How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before)
Time frame: up to december 2012 (up to 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
- Derived from this study: PubMed 25633037Giorgi Rossi P, Fortunato C, Barbarino P, Boveri S, Caroli S, Del Mistro A, Ferro A, Giammaria C, Manfredi M, Moretto T, Pasquini A, Sideri M, Tufi MC, Cogo C, Altobelli E; HPV Self-sampling Italian Working Group. Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter. Br J Cancer. 2015 Feb 17;112(4):667-75. doi: 10.1038/bjc.2015.11. Epub 2015 Jan 29.
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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.
Emma Altobelli, Prof. study director
AUSL4 Teramo - Italy
1 site 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 Cin Grade, run by Azienda Sanitaria Locale 4, Teramo at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performing a HPV test within 3 months since the recall letter (time frame: up to december 2012 (up to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647724, which also lists 1 linked publication.
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 24 Jul 2012.