Cervical Cancer Clinical Trial
— CASSISOfficial title:
Cervical And Self-Sample In Screening (CASSIS) Study: Diagnostic Performance of Molecular HPV Testing With the Eve Medical Self-collection System© for Detecting Cervical Intraepithelial Neoplasia
Verified date | August 2016 |
Source | McGill University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Institutional Review Board |
Study type | Interventional |
The proposed study seeks to compare the diagnostic performance of Human Papillomavirus (HPV)
testing in self-collected samples via the Eve Medical self-collection system© (Eve) with
standard physician-collected samples for the detection of cervical intraepithelial neoplasia
grade 1 or worse (CIN1+) and cervical cancer among women referred for colposcopy. The
performance of the Eve sample will also be compared with that of a second self-sample via a
cobas® PCR Female swab.
Approximately 1000 adult women with an abnormal Pap test at the level of an atypical
squamous cells of undetermined significance or worse squamous or glandular abnormality
(i.e., ASCUS+) or an abnormal co-test (ASCUS+ and HPV-positive) result will be recruited
over a period of 12 months via colposcopy clinics located at the Jewish General Hospital,
St-Mary's Hospital, and the McGill University Health Centers (Royal Victoria Hospital).
Participating women will undergo three cervical or cervicovaginal sampling techniques: 1)
self-sampling using the Eve Medical self-collection system©; 2) self-sampling using a cobas®
PCR Female swab; and 3) physician-collected sampling. The participants will also fill in a
questionnaire on their experience with the convenience and acceptability of the Eve system,
relative to the other two sampling approaches. The decision as to which self-sample is to be
collected first will be dependent on randomization
HPV testing will be done using the cobas® 4800 HPV Test. The liquid medium of within the
cobas® PCR CELL Collection Media with the provider collected sample and the cobas® PCR media
with the two self-collected samples will be used to suspend the cellular material prior to
HPV testing. We have made collaborative arrangements with Dr. Marcel Behr, Chief of the
Department of Clinical Microbiology at the McGill University Health Centre for the HPV
genotyping work.
Histology-confirmed CIN1+ will form the study outcome or case definition. Sensitivity,
specificity, and predictive values (along with their respective 95% confidence intervals)
will be calculated for each sample type to evaluate the clinical performance of the various
sampling techniques. We will use CIN1+ as definition of disease but analyses will also be
performed for more stringent definitions, e.g. CIN2+ or CIN3/cancer.
Status | Completed |
Enrollment | 1225 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women of all ages are eligible to the study if they have been referred to the participating colposcopy clinic because of an abnormal Pap test at the level of an atypical squamous cells of undetermined significance or worse squamous or glandular abnormality (i.e., ASCUS+) or an abnormal co-test (ASCUS+ and HPV-positive) result. Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
Canada | McGill University - Division of Cancer Epidemiology | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences by comparison groups in detection of histologically confirmed Cervical Intraepithelial Neoplasia grade 1 or worse (CIN1+) | Diagnostic accuracy (sensitivity and specificity with 95% confidence intervals, and predictive values will be determined for each sample type to evaluate the clinical performance of the various sampling techniques. The investigators hypothesize that the Eve sample will yield sensitivity and specificity results that are no worse than those with the physician-collected sample, while providing better or equivalent results than those with the self-sample based on the CobasĀ® PCR Female swab. | Cross-Sectional (1 year-period to accrue patients) | No |
Secondary | Patient satisfaction and experience using the self-sampling devices | Participants will be asked to fill out a questionnaire consisting of 10 questions on ease of use, comfort, embarrassment, and clarity of instructions when using self-sampled cervicovaginal sampling such as the HerSwabTM and the female polyester swab as compared to the physician-collected sample. The investigators hypothesize similar patient satisfaction with the three sampling approaches. | Cross-Sectional (1 year-period) | No |
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