Feasibility of Delphi Screener for Cervical Cytology
The aim of this study is to see whether a new self-sampling device, the Delphi Screener (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The results using the new device will be compared to results using the current gold standard. The gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions.
The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City|
- Sensitivity and Specificity [ Time Frame: 1-3 months between 2 specimen collections ] [ Designated as safety issue: No ]
We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results.
The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints.
- Kappa Coefficient [ Time Frame: 1-3 months between 2 specimen collections ] [ Designated as safety issue: No ]Kappa comparing clinician-collected cytology result to self-lavage cytology result
- Outcome: Acceptability of Device [ Time Frame: cross-sectional - asked at time of Screener use ] [ Designated as safety issue: Yes ]On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening
|Study Start Date:||September 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Single arm study
Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)
Device: Delphi Screener
Self-sampling device for cervical vaginal lavage
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702208
|United States, New York|
|Columbia University Presbyterian Hospital|
|New York, New York, United States, 10032|
|Principal Investigator:||Carolyn Westhoff, MD||Columbia University|