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Self Collected Sampling in Non-attendees Cervical Cancer Screening: DNA Test and Molecular Triage for HPV Positive Women

NCT03183700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2018-07-17

No results posted yet for this study

Summary

The aims of the present study are to assess the effects of a hrHPV self-sampling test as strategies to reach non-attending women in organized cervical screening in comparison with standard recall by letter in 8000 women; to evaluate the performance of two self sampling devices with and without a preservative buffer and to explore their acceptability among invited women and to evaluate a molecular triage approach for management of HPV positive women in self sampling collected material by HPV genotyping and DNA methylation marker panel

Conditions

Interventions

DEVICE

Self sampling device

The investigators will allocate randomly the women to two different self sampling devices differing in having or not a preservative buffer

OTHER

Cervical ThinPrep sampling

Women are inviated with a standard invitation letter to perform cervical ThinPrep sampling at the clinic on a pre-fixed date

Sponsors & Collaborators

  • Istituto Toscano Tumori

    collaborator OTHER

  • Cancer Prevention and Research Institute, Italy

    lead OTHER

Principal Investigators

  • Francesca M Carozzi, PhD · Cancer prevention and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Model
PARALLEL

Eligibility

Min Age
34 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-09
Primary Completion
2017-08-09
Completion
2018-08-09

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03183700 on ClinicalTrials.gov