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IT-system Development for Reaching Cervix Cancer Screening Non-attenders

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ClinicalTrials.gov Identifier: NCT02750124
Recruitment Status : Unknown
Verified April 2016 by Joakim Dillner, Karolinska Institutet.
Recruitment status was:  Enrolling by invitation
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Collaborator:
Regional Cancer Centre Stockholm Gotland
Information provided by (Responsible Party):
Joakim Dillner, Karolinska Institutet

Brief Summary:
The main purpose is to develop and test an IT-infrastructure to provide more individualized ways of inviting and reaching women who have not participated, despite having been invited with annual reminders, in cervix cancer screening program during a ten year period.

Condition or disease Intervention/treatment Phase
Human Papillomavirus DNA Tests Cervical Cancer Device: Cobas PCR Female swab sample Packet Other: Routine practice Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: IT-system Development for Individualization of Cervix Cancer Screening and Implementation of New Strategies to Reach Non-attenders
Study Start Date : March 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Active Comparator: HPV self sampling test sent
A Cobas PCR (polymerase chain reaction) Female swab sample Packet will be sent directly to women with a study invitation letter and instructions. Response rate will be measured.
Device: Cobas PCR Female swab sample Packet
The cobas® PCR Female Swab Sample Kit is used to collect and transport vaginal swab specimens self-collected.

Active Comparator: HPV self sampling test ordered
An invitation to order a Cobas PCR Female swab sample Packet through an online application will be sent. Response rates will be measured.
Device: Cobas PCR Female swab sample Packet
The cobas® PCR Female Swab Sample Kit is used to collect and transport vaginal swab specimens self-collected.

Active Comparator: Nurse navigator contact
An invitation to call the coordinating midwife with questions and concerns regarding screening will be sent. The coordinating midwife can help the participant order a Cobas PCR Female swab sample Packet or book a standard screening visit, if desired. Response rates will be measured
Device: Cobas PCR Female swab sample Packet
The cobas® PCR Female Swab Sample Kit is used to collect and transport vaginal swab specimens self-collected.

Other: Routine practice
The standard, annual renewed invitation to cervical screening.

Placebo Comparator: Control
The standard, annual renewed invitation to cervical screening will be sent (control, routine practice). Response rate will be measured as a baseline.
Other: Routine practice
The standard, annual renewed invitation to cervical screening.




Primary Outcome Measures :
  1. Proportion of women responding (either by and HPV test or a Pap test) [ Time Frame: From recruitment until end of study on December 31st 2016 (average 8 months) ]
    Participation rate in screening



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Ages Eligible for Study:   33 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-participants in cervical cancer screening during a 10 year period

Exclusion Criteria:

  • Active refusers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750124


Sponsors and Collaborators
Karolinska Institutet
Regional Cancer Centre Stockholm Gotland
Investigators
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Principal Investigator: Joakim Dillner, MD Karolinska Institutet

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Responsible Party: Joakim Dillner, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02750124     History of Changes
Other Study ID Numbers: NIASC 62721
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Our intention is to share data, but a plan for how this will be done in practise has not been written.

Keywords provided by Joakim Dillner, Karolinska Institutet:
participation
self sampling
Screening

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female