Contact information
Type
Scientific
Primary contact
Mr Paolo Giorgi Rossi
ORCID ID
Contact details
Laziosanità - Agenzia di Sanità Pubblica
Regione Lazio
via di S. Costanza 53
Rome
00198
Italy
giorgirossi@asplazio.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of a self-sampling device for human papillomavirus (HPV) test on the women's participation to cervical cancer screening in Italy: a four-arm randomised controlled trial
Acronym
Study hypothesis
The use of a self-sampler may remove some of the barriers for women's participation to cervical cancer screening programs.
Ethics approval
The Ethical Committee of ISPO, a Cancer Prevention and Study Centre, approved on the 6th June 2008 (ref: 6)
Study design
Four-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Cervical cancer prevention
Intervention
Control 1: standard recall letter to perform Pap test at the clinic
Control 2: standard recall letter to perform Pap test at the clinic
Intervention 1: direct mailing of the self sampling device at home
Intervention 2: invitation to contact the centre to receive the self sampling device at home
Total duration of follow-up for all arms: 3 months.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measures
Performing a test (HPV or Pap) within 3 months since the recall letter.
Secondary outcome measures
How many of the women performing a test after the intervention were never-screened or under-screened (last Pap test more than 3 years before)?
Overall trial start date
01/02/2009
Overall trial end date
20/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All women (aged 35 - 64 years) non-responding to the screening invitation in the previous year and eligible for recall
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600 women per arm (total 2400)
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/02/2009
Recruitment end date
20/11/2009
Locations
Countries of recruitment
Italy
Trial participating centre
Laziosanità - Agenzia di Sanità Pubblica, Regione Lazio
Rome
00198
Italy
Sponsor information
Organisation
Centre for Disease Control and Prevention, Italian Ministry of Health (Italy)
Sponsor details
Viale Giorgio Ribotta
5
Rome
00144
Italy
an.federici@sanita.it
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Centre for Disease Control and Prevention, Italian Ministry of Health (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21179038
Publication citations
-
Results
Giorgi Rossi P, Marsili LM, Camilloni L, Iossa A, Lattanzi A, Sani C, Di Pierro C, Grazzini G, Angeloni C, Capparucci P, Pellegrini A, Schiboni ML, Sperati A, Confortini M, Bellanova C, D'Addetta A, Mania E, Visioli CB, Sereno E, Carozzi F, , The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600)., Br. J. Cancer, 2011, 104, 2, 248-254, doi: 10.1038/sj.bjc.6606040.