SElf-SAMpling in Cervical Cancer Screening; SESAM Study

NCT02945891 | Unknown

• 2 other identifiers: 2014/6555777899
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 4

Brief 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

Cervical Cancer

Keywords

mass screening; coverage; self-sampling; clinical validity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall and hrHPV specific concordance between self- and clinician-sampled specimens

  Through study completion, an average of 6 months

• Acceptability of feasibility of self-sampling

  Through study completion, an average of 6 months

• Participants screening history and reasons for possible non-participation

  Through study completion, an average of 6 months

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

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

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.

Study group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women with mild cervical lesions

Sponsors & Collaborators

• Oslo University Hospital: lead
• Ostfold Hospital Trust: collaborator

Study Sites (4)

Ostfold Hospital Trust

Fredrikstad, Norway

Location

Oslo University Hospital, Molecular Pathology

Oslo, Norway

Location

Oslo University Hospital, Ullevål

Oslo, Norway

Location

Radiumhospital

Oslo, Norway

Location

Related Publications (1)

• Leinonen MK, Schee K, Jonassen CM, Lie AK, Nystrand CF, Rangberg A, Furre IE, Johansson MJ, Trope A, Sjoborg KD, Castle PE, Nygard M. Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions. J Clin Virol. 2018 Feb-Mar;99-100:22-30. doi: 10.1016/j.jcv.2017.12.008. Epub 2017 Dec 21.

  PMID: 29289814 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Giske Ursin, MD, Prof

  Oslo University Hospital, Cancer Registry of Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Officer, Head of HPV-related Epiemiological Research Unit

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 26, 2016
• Study Start: April 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)