Feasibility of Delphi Screener for Cervical Cytology

Phase 2

Completed

• Conditions: Cervical Neoplasia
• Interventions: Device: Delphi Screener

• Registration Number: NCT00702208
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Study Start: 2008-09
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-07
• Results First Submitted: 2013-07-29
• Results First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Results First Posted: 2014-01-13
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 198

Inclusion Criteria

• Valid Pap smear in last 1-3 months obtained at participating clinic
• 18 years or older
• Self-report being able to read in English and/or Spanish
• Willing to sign informed consent

Exclusion Criteria

• Used vaginal product (douche, spermicide, antifungal) in last 48 hours
• Last menses started ≤ 4 days prior to enrollment visit
• No uterus / history of hysterectomy
• Self-report currently pregnant
• Self-report currently breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	Delphi Screener	Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	1-3 months between 2 specimen collections	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	1-3 months between 2 specimen collections	Kappa comparing clinician-collected cytology result to self-lavage cytology result

Secondary Outcome Measures

Name	Time	Method
Outcome: Acceptability of Device	cross-sectional - asked at time of Screener use	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

Trial Locations

Locations (1)

Columbia University Presbyterian Hospital; 🇺🇸 New York, New York, United States