Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Feasibility of Delphi Screener for Cervical Cytology

This study has been completed.
Sponsor:
Collaborator:
Delphi Devices BV
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier:
NCT00702208
First received: May 30, 2008
Last updated: December 12, 2013
Last verified: July 2013
Results First Received: July 29, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Cervical Neoplasia
Intervention: Device: Delphi Screener

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided by Columbia University

Publications automatically indexed to this study:

Responsible Party: Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier: NCT00702208     History of Changes
Other Study ID Numbers: AAAD1382
Study First Received: May 30, 2008
Results First Received: July 29, 2013
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board