NCT00702208|CompletedPhase 2Results
Feasibility of Delphi Screener for Cervical Cytology
The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
Loading search results
Sponsor study identifier
interventional
198
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2008
Actual (reported)June 20, 2008
Actual (reported)September 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 2010
Actual (reported)January 2010
Actual (reported)January 13, 2014
Actual (reported)Sensitivity and Specificity
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.
1-3 months between 2 specimen collections
Kappa Coefficient
Kappa comparing clinician-collected cytology result to self-lavage cytology result
1-3 months between 2 specimen collections
Outcome: Acceptability of Device
cross-sectional - asked at time of Screener use
Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)
Self-sampling device for cervical vaginal lavage
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Columbia University Presbyterian Hospital
New York, New York, 10032, United States
Jones HE, Mansukhani MM, Tong GX, Westhoff CL. Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. PLoS One. 2013 Dec 20;8(12):e82115. doi: 10.1371/journal.pone.0082115. eCollection 2013.
Carolyn Westhoff, MD
Columbia University
198 participants (actual enrollment reported by the registry).
First Submitted
May 30, 2008
First Posted
June 20, 2008
Study Start
September 2008
Date type not reportedEvaluating Thermal Ablation in the Treatment of Cervical Neoplasia
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
January 13, 2014
Results First Posted
January 13, 2014
Record last verified: 2013-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: