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Feasibility of Delphi Screener for Cervical Cytology

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702208
First Posted: June 20, 2008
Last Update Posted: January 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Delphi Devices BV
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University
Results First Submitted: July 29, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition: Cervical Neoplasia
Intervention: Device: Delphi Screener

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from cervical cancer screening patients from three ambulatory clinics at the New York Presbyterian Hospital from December 1, 2008 to August 31, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligiblity criteria for participation were: 18 years of age or older, not currently pregnant, not currently breastfeeding, self-reported comfort reading in English or Spanish or their own. Women were scheduled to attend the clinic to use the self-lavaging device 1-3 months after their standard-of-care cervical cancer screening.

Reporting Groups
  Description
Single Arm Study of Delphi Screener

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

All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room.


Participant Flow:   Overall Study
    Single Arm Study of Delphi Screener
STARTED   198 
COMPLETED   167 
NOT COMPLETED   31 
Lost to Follow-up                28 
Did not self-lavage                1 
Unsatisfactory colposcopy                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Arm Study Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)

Baseline Measures
   Single Arm Study 
Overall Participants Analyzed 
[Units: Participants]
 198 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   195 
>=65 years   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.6  (13.0) 
Gender 
[Units: Participants]
 
Female   198 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   198 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sensitivity and Specificity   [ Time Frame: 1-3 months between 2 specimen collections ]

2.  Primary:   Kappa Coefficient   [ Time Frame: 1-3 months between 2 specimen collections ]

3.  Secondary:   Outcome: Acceptability of Device   [ Time Frame: cross-sectional - asked at time of Screener use ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Heidi Jones
Organization: CUNY School of Public Health, Hunter College
phone: 212-396-7750
e-mail: hjon@hunter.cuny.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier: NCT00702208     History of Changes
Other Study ID Numbers: AAAD1382
First Submitted: May 30, 2008
First Posted: June 20, 2008
Results First Submitted: July 29, 2013
Results First Posted: January 13, 2014
Last Update Posted: January 13, 2014