Trial Outcomes & Findings for Feasibility of Delphi Screener for Cervical Cytology (NCT NCT00702208)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

198 participants

Primary outcome timeframe

1-3 months between 2 specimen collections

Results posted on

2014-01-13

Participant Flow

Recruitment from cervical cancer screening patients from three ambulatory clinics at the New York Presbyterian Hospital from December 1, 2008 to August 31, 2009.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	198
Overall Study COMPLETED	167
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	28
Overall Study Did not self-lavage	1
Overall Study Unsatisfactory colposcopy	2

Baseline Characteristics

Feasibility of Delphi Screener for Cervical Cytology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Study n=198 Participants Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	195 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	34.6 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	198 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	198 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Study of Delphi Screener n=167 Participants Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
Sensitivity and Specificity sensitivity	0.86 % of participants correctly diagnosed Interval 0.42 to 1.0
Sensitivity and Specificity specificity	0.80 % of participants correctly diagnosed Interval 0.73 to 0.96

PRIMARY outcome

Timeframe: 1-3 months between 2 specimen collections

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

Outcome measures

Outcome measures
Measure	Single Arm Study of Delphi Screener n=167 Participants Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
Kappa Coefficient	0.36 kappa coefficient for paired specimens Interval 0.25 to 0.47

SECONDARY outcome

Timeframe: cross-sectional - asked at time of Screener use

Population: For acceptability, 197 women used the device; 30 of these women did not have valid gold standard results but did respond to acceptability, thus for acceptability endpoint the sample size is 197 (while the sample size is 167 for sensitivity, specificity and kappa analyses due to insufficient sepcimens /loss to follow-up for colposcopy).

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

Outcome measures

Outcome measures
Measure	Single Arm Study of Delphi Screener n=197 Participants Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
Outcome: Acceptability of Device	9.6 units on a scale Interval 7.1 to 9.9

Adverse Events

Single Arm Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heidi Jones

CUNY School of Public Health, Hunter College

Phone: 212-396-7750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place