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

This study is not yet open for participant recruitment.
Verified May 2012 by Azienda Sanitaria Locale 4, Teramo
Sponsor:
Information provided by (Responsible Party):
Emma Altobelli, Azienda Sanitaria Locale 4, Teramo
ClinicalTrials.gov Identifier:
NCT01647724
First received: July 17, 2012
Last updated: July 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Cervical Cancer Cin Grade

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Sanitaria Locale 4, Teramo:

Primary Outcome Measures:
  • performing a HPV test within 3 months since the recall letter [ Time Frame: up to december 2012 (up to 3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

vaginal washings


Estimated Enrollment: 15000
Study Start Date: September 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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).

  Eligibility

Ages Eligible for Study:   35 Years to 64 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647724

Locations
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
Study Director: Emma Altobelli, Prof. AUSL4 Teramo - Italy
  More Information

No publications provided

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
Study First Received: July 17, 2012
Last Updated: July 23, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Sanitaria Locale 4, Teramo:
cervical cancer
prevention
screening

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 13, 2013