Condition category
Cancer
Date applied
24/08/2009
Date assigned
18/05/2010
Last edited
24/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ministerosalute.it/

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

  1. 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.

Additional files

Editorial Notes