SElf-SAMpling in Cervical Cancer Screening; SESAM Study (SESAM)

April 5, 2017 updated by: Mari Nygård, Oslo University Hospital

SElf-SAMpling in Cervical Cancer Screening. SESAM Study; a Key to Better Health. Clinical Validation of a Self-sampling Device in Patients With Cervical Cancer and Cervical Pre-invasive Neoplasia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Concept of collecting cervical cancer screening smear in home through self-sampling is new both for target population and medical professionals. Self-sampling increases screening attendance and could be an alternative to recruit more women to cervical cancer screening in Norway. As there are is an implementation ongoing to switch from cytology based screening to HPV based screening in Norway, a reliable self-sampling method for HPV testing should be available. Furthermore, detection of HPV from self-sampled specimen requires laboratory capacity and expertise to comply with quality assurance demands such as internal quality control, external quality assessment and quality improvement. National studies are crucial to obtain knowledge and build expertize among health care providers. This study aims to show non-inferior sensitivity of hrHPV testing on self-sampled vs. clinician-sampled specimens to detect high-grade cervical lesions and cancer (CIN2+). Additionally we will;

  • Evaluate overall and hrHPV type specific concordance between self-taken and physician-taken samples.
  • Evaluate participants views on feasibility and acceptability of self-sampling (questionnaire)
  • Compare participants screening history with the questionnaire to evaluate the reason for not participating in the national screening program (if that is the case).
  • Biobank biological material collected from self-sample, physician taken samples, blood and urine, for future analysis on HPV-related diseases and cancer.

Study participants will be recruited from the colposcopy referrals and cancer care units from three different hospitals. Patients with CIN 2 or CIN 3 lesions (n=200) will be recruited from Oslo University Hospital, Ullevål and Østfold Hospital Trust, while cancer patients (n=50) will be recruited from Radiumhospital.

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Fredrikstad, Norway
        • Ostfold Hospital Trust
      • Oslo, Norway
        • Oslo University Hospital, Molecular Pathology
      • Oslo, Norway
        • Oslo University Hospital, Ullevål
      • Oslo, Norway
        • Radiumhospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with histological verified CIN 2 or CIN 3
  • Women with histological verified cervical cancer

Exclusion Criteria:

  • Women with mild cervical lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Each women recruited for the study belong to the study group. Intervention is performance of HPV testing on Evalyn®Brush and FloqSwab specimens compared to clinician-sampled specimen. Providing an urinary sample (Colli-PeeTM), blood, and a questionnaire data is optional.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High-risk HPV (hrHPV) testing on self-sampled specimens has non-inferior sensitivity for CIN 2+ compared to clinician-sampled specimens.
Time Frame: Sensitivity will be assessed through study completion, up to 36 months
Relative sensitivity will be measured through histologically confirmed detection rates using clinician-sampled specimen as a reference.
Sensitivity will be assessed through study completion, up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall and hrHPV specific concordance between self- and clinician-sampled specimens
Time Frame: Through study completion, an average of 6 months
Agreement of hrHPV positivity rates between self-collected samples and physician-collected reference samples will be assessed by the kappa statistic.
Through study completion, an average of 6 months
Acceptability of feasibility of self-sampling
Time Frame: Through study completion, an average of 6 months
We will evaluate the acceptability of different self-sampling devices based on the participants' views from a questionnaire.
Through study completion, an average of 6 months
Participants screening history and reasons for possible non-participation
Time Frame: Through study completion, an average of 6 months
We will evaluate reasons for possible non-participation based on the participants' responses from a questionnaire and individual screening records at the Cancer Registry of Norway.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Ostfold Hospital Trust

Investigators

  • Study Director: Giske Ursin, MD, Prof, Oslo University Hospital, Cancer Registry of Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/655
  • 5777899 (Other Grant/Funding Number: Cancer Society of Norway)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We can't make individual participant data available due to restrictions set by the ethical approval and the informed consent. Our data contains several variables with personal health information, including age, dates, test results and diagnoses. Even without direct identifiers, it would be possible for a person to recognize herself from the dataset and that is strictly forbidden.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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