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

A

Azienda Sanitaria Locale 4, Teramo

Status

Unknown

Conditions

Cervical Cancer Cin Grade

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

15,000 estimated patients

Sex

Female

Ages

35 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

15,000 participants in 3 patient groups

control 1
Description:
standard recall letter to perform HPV test at the clinic
Intervention 1
Description:
direct mailing of the self sampling device at home
intervention 2
Description:
invitation to retire the self sampling device in local pharmacy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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