Cervical And Self-Sample In Screening Study (CASSIS)
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|ClinicalTrials.gov Identifier: NCT02397252|
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : August 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Intraepithelial Neoplasia||Device: Eve Medical self-collection system© Device: cobas® PCR Female swab self-sampling Procedure: Physician-collected sampling||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1225 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official 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|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Eve Medical self-collection system©
Device: Self-sampling swab from Eve Medical for collection of vaginal cells.
Device: Eve Medical self-collection system©
The Eve collection system is a plastic device not much bigger than a tampon that is inserted in the vaginal cavity. A silicone brush is then swiped around the vagina to scrape a few vaginal cells for cervical cancer screening.
Other Name: HerSwabTM
Placebo Comparator: cobas® PCR Female swab self-sampling
Device: Regular polyester swab for collection of vaginal cells.
Device: cobas® PCR Female swab self-sampling
Regular polyester swab for collection of vaginal cells.
Other Name: Long swab
Placebo Comparator: Physician-collected sampling
Routine colposcopy sample collected by a physician.
Procedure: Physician-collected sampling
Routine colposcopy sample collected by a physician.
- Differences by comparison groups in detection of histologically confirmed Cervical Intraepithelial Neoplasia grade 1 or worse (CIN1+) [ Time Frame: Cross-Sectional (1 year-period to accrue patients) ]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 Cobas® PCR Female swab.
- Patient satisfaction and experience using the self-sampling devices [ Time Frame: Cross-Sectional (1 year-period) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397252
|McGill University - Division of Cancer Epidemiology|
|Montreal, Quebec, Canada, H2W 1S6|
|Principal Investigator:||Eduardo Franco, DrPH||McGill University|
|Study Director:||Mariam El-Zein, PhD||McGill University|