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New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening (NMDSS2)

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ClinicalTrials.gov Identifier: NCT01647724
Recruitment Status : Unknown
Verified May 2012 by Emma Altobelli, Azienda Sanitaria Locale 4, Teramo.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2012
Last Update Posted : July 24, 2012
Sponsor:
Information provided by (Responsible Party):
Emma Altobelli, Azienda Sanitaria Locale 4, Teramo

Study Description
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Brief 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. 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.


Condition or disease
Cervical Cancer Cin Grade

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
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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : September 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. performing a HPV test within 3 months since the recall letter [ Time Frame: up to december 2012 (up to 3 months) ]

Secondary Outcome Measures :
  1. 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) ]

Biospecimen Retention:   Samples Without DNA
vaginal washings

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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).
Criteria

Inclusion Criteria:

All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall

Exclusion Criteria:

does not meet inclusion criteria

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647724


Locations
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Italy
AUSL4 Teramo Not yet recruiting
Teramo, TE, Italy, 64100
Contact: Emma Altobelli, Prof.    0861420280 ext +39    amedeo.lattanzi@aslteramo.it   
Principal Investigator: Emma Altobelli, Prof.         
Sponsors and Collaborators
Azienda Sanitaria Locale 4, Teramo
Investigators
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Study Director: Emma Altobelli, Prof. AUSL4 Teramo - Italy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Emma Altobelli, Responsable U.O. Epidemiology and Social Marketing, Azienda Sanitaria Locale 4, Teramo
ClinicalTrials.gov Identifier: NCT01647724     History of Changes
Other Study ID Numbers: NMD2TE
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: May 2012
Keywords provided by Emma Altobelli, Azienda Sanitaria Locale 4, Teramo:
cervical cancer
prevention
screening
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female