SElf-SAMpling in Cervical Cancer Screening; SESAM Study

Cervical Cancer Clinical Trial

— SESAM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02945891
• Other study ID #: 2014/655
• Secondary ID: 5777899
• Status: Active, not recruiting
• Phase: N/A
• First received: October 21, 2016
• Last updated: April 5, 2017
• Start date: April 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women with histological verified CIN 2 or CIN 3

• Women with histological verified cervical cancer

Exclusion Criteria:

• Women with mild cervical lesions

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Fredrikstad
Norway	Oslo University Hospital, Molecular Pathology	Oslo
Norway	Oslo University Hospital, Ullevål	Oslo
Norway	Radiumhospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-risk HPV (hrHPV) testing on self-sampled specimens has non-inferior sensitivity for CIN 2+ compared to clinician-sampled specimens.	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	Overall and hrHPV specific concordance between self- and clinician-sampled specimens	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
Secondary	Acceptability of feasibility of self-sampling	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
Secondary	Participants screening history and reasons for possible non-participation	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