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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
Sponsor:
Information provided by (Responsible Party):
Dr. Eduardo Franco, McGill University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1225 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • none

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
McGill University - Division of Cancer Epidemiology
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
McGill University
Investigators
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Principal Investigator: Eduardo Franco, DrPH McGill University
Study Director: Mariam El-Zein, PhD McGill University

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Responsible Party: Dr. Eduardo Franco, James McGill Professor in the Departments of Oncology and Epidemiology & Biostatistics, Director, Division of Cancer Epidemiology, and Chairman, Department of Oncology, at McGill University's Faculty of Medicine, McGill University
ClinicalTrials.gov Identifier: NCT02397252     History of Changes
Other Study ID Numbers: A11-M103-14B
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by Dr. Eduardo Franco, McGill University:
Human Papillomavirus
Screening
Self-collection test
Pap test

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type