Feasibility of Delphi Screener for Cervical Cytology

Columbia University198 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

198

Conditions

Cervical Neoplasia

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1-3 months between 2 specimen collections

Kappa Coefficient

Kappa comparing clinician-collected cytology result to self-lavage cytology result

Time frame: 1-3 months between 2 specimen collections

Secondary Outcomes

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

Time frame: cross-sectional - asked at time of Screener use