Brief Title
Feasibility of Delphi Screener for Cervical Cytology
Official Title
The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Sensitivity and Specificity
Secondary Outcome
Outcome: Acceptability of Device
Condition
Cervical Neoplasia
Intervention
Delphi Screener
Study Arms / Comparison Groups
Single arm study
Description: Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
198
Start Date
September 2008
Completion Date
January 2010
Primary Completion Date
January 2010
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Carolyn Westhoff, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00702208
Organization ID
AAAD1382
Responsible Party
Principal Investigator
Study Sponsor
Columbia University
Collaborators
Delphi Devices BV
Study Sponsor
Carolyn Westhoff, MD, Principal Investigator, Columbia University
Verification Date
July 2013