Cervical And Self-Sample In Screening Study

NCT02397252 | Completed DMC

• 1 other identifier: A11-M103-14B
• Study Type: interventional
• Target: 1,225
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Intraepithelial Neoplasia

Keywords

Human Papillomavirus; Screening; Self-collection test; Pap test

Outcome Measures

Primary Outcomes (1)

• 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 Cobas® PCR Female swab.

  Cross-Sectional (1 year-period to accrue patients)

Secondary Outcomes (1)

• Patient satisfaction and experience using the self-sampling devices

  Cross-Sectional (1 year-period)

Study Arms (3)

Eve Medical self-collection system©

EXPERIMENTAL

Device: Self-sampling swab from Eve Medical for collection of vaginal cells.

Device: Eve Medical self-collection system©

cobas® PCR Female swab self-sampling

PLACEBO COMPARATOR

Device: Regular polyester swab for collection of vaginal cells.

Device: cobas® PCR Female swab self-sampling

Physician-collected sampling

PLACEBO COMPARATOR

Routine colposcopy sample collected by a physician.

Procedure: Physician-collected sampling

Interventions

Eve Medical self-collection system© DEVICE

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.

Also known as: HerSwabTM

Eve Medical self-collection system©

cobas® PCR Female swab self-sampling DEVICE

Regular polyester swab for collection of vaginal cells.

Also known as: Long swab

cobas® PCR Female swab self-sampling

Physician-collected sampling PROCEDURE

Routine colposcopy sample collected by a physician.

Physician-collected sampling

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University - Division of Cancer Epidemiology

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Carcinoma in Situ

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Eduardo Franco, DrPH

  McGill University

  PRINCIPAL INVESTIGATOR

• Mariam El-Zein, PhD

  McGill University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 24, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

CA (1)