Feasibility of Delphi Screener for Cervical Cytology

Cervical Neoplasia Clinical Trial

Official title:

The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702208
• Other study ID #: AAAD1382
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2008
• Last updated: December 12, 2013
• Start date: September 2008
• Est. completion date: January 2010

Study information

• Verified date: July 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Cervical Neoplasia

Intervention

Device:
• Delphi Screener
Self-sampling device for cervical vaginal lavage

Locations

Country	Name	City	State
United States	Columbia University Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Delphi Devices BV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Kappa Coefficient	Kappa comparing clinician-collected cytology result to self-lavage cytology result	1-3 months between 2 specimen collections	No
Secondary	Outcome: Acceptability of Device	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	cross-sectional - asked at time of Screener use	Yes