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Completed

NCT Number: NCT00702208

Feasibility of Delphi Screener for Cervical Cytology

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.

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Key information

Conditions

Cervical Neoplasia Antisocial Personality Disorder Mental Disorders Personality Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University Presbyterian Hospital

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delphi Screener

Device

Self-sampling device for cervical vaginal lavage

Other names: Pantarhei Screener, Mermaid

Primary outcomes

  1. Sensitivity and Specificity

    Time frame: 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.

  2. Kappa Coefficient

    Time frame: 1-3 months between 2 specimen collections

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

Secondary outcomes

  1. Outcome: Acceptability of Device

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Delphi Devices BV

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 20, 2008
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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