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Trial Title:
New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening
NCT ID:
NCT01647724
Condition:
Cervical Cancer Cin Grade
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer
prevention
screening
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
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).
Criteria for eligibility:
Study pop:
Involving 15000 women non-responders to previous calls in five different screening
programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
Sampling method:
Probability Sample
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
Gender:
Female
Minimum age:
35 Years
Maximum age:
64 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
AUSL4 Teramo
Address:
City:
Teramo
Zip:
64100
Country:
Italy
Contact:
Last name:
Emma Altobelli, Prof.
Phone:
0861420280
Phone ext:
+39
Email:
amedeo.lattanzi@aslteramo.it
Investigator:
Last name:
Emma Altobelli, Prof.
Email:
Principal Investigator
Start date:
September 2012
Completion date:
March 2013
Lead sponsor:
Agency:
Azienda Sanitaria Locale 4, Teramo
Agency class:
Other
Source:
Azienda Sanitaria Locale 4, Teramo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01647724
