NCT00702208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

January 13, 2014

Completed
Last Updated

January 13, 2014

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

May 30, 2008

Results QC Date

July 29, 2013

Last Update Submit

December 12, 2013

Conditions

Cervical Neoplasia

Keywords

cervical cytologyPap smearself-samplingabnormalnormal

Outcome Measures

Primary Outcomes (2)

  • 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

  • Kappa Coefficient

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

    1-3 months between 2 specimen collections

Secondary Outcomes (1)

  • Outcome: Acceptability of Device

    cross-sectional - asked at time of Screener use

Study Arms (1)

Single arm study

OTHER

Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)

Device: Delphi Screener

Interventions

Delphi ScreenerDEVICE

Self-sampling device for cervical vaginal lavage

Also known as: Pantarhei Screener, Mermaid
Single arm study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

  • Jones HE, Mansukhani MM, Tong GX, Westhoff CL. Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. PLoS One. 2013 Dec 20;8(12):e82115. doi: 10.1371/journal.pone.0082115. eCollection 2013.

    PMID: 24376516DERIVED

MeSH Terms

Conditions

Antisocial Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Results Point of Contact

Title
Heidi Jones
Organization
CUNY School of Public Health, Hunter College
hjon@hunter.cuny.edu
212-396-7750

Study Officials

  • Carolyn Westhoff, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 20, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 13, 2014

Results First Posted

January 13, 2014

Record last verified: 2013-07

Locations

US(1)