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SElf-SAMpling in Cervical Cancer Screening; SESAM Study

NCT02945891 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2017-04-06

No results posted yet for this study

Summary

Study aims to support development of evidence based health care in Norway through evaluating recently proposed technological improvements in cervical cancer control before their routine use. SESAM II study evaluates the accuracy of vaginal self-sampling for high risk human papillomavirus (hrHPV) testing compared with a physician-taken sample.

Conditions

Interventions

DEVICE

HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens

Each woman use the self-sampling devices in an advised order the day before they go to the hospital. There will be change of sampling order with every patient so that 50% of women will use Evalyn®Brush (Rovers Medical Devices, Oss, The Netherlands) first and 50% a FloqSwab (Coban Flock Technologies, Italy) first. In addition women are asked to provide a first void urine sample using a Colli-PeeTM (Novosanis, Belgium) on the same morning as the hospital visit. At the hospital clinician will take an additional specimen for which the performance of different self-sampling devices will be compared to.

Sponsors & Collaborators

  • Ostfold Hospital Trust

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Giske Ursin, MD, Prof · Oslo University Hospital, Cancer Registry of Norway

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Norway

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 NCT02945891 on ClinicalTrials.gov