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

Cervical Cancer Cin Grade Clinical Trial

— NMDSS2  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01647724
• Other study ID #: NMD2TE
• Status: Not yet recruiting
• Phase: N/A
• First received: July 17, 2012
• Last updated: July 23, 2012
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2012
• Source: Azienda Sanitaria Locale 4, Teramo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15000
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer Cin Grade
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Italy	AUSL4 Teramo	Teramo	TE

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale 4, Teramo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performing a HPV test within 3 months since the recall letter		up to december 2012 (up to 3 months)	No
Secondary	How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before)		up to december 2012 (up to 3 months)	No