Cervical Neoplasia
Conditions
Keywords
cervical cytology, Pap smear, self-sampling, abnormal, normal
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.
Interventions
DEVICEDelphi Screener
Self-sampling device for cervical vaginal lavage
Sponsors
Delphi Devices BV
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | 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. |
| Kappa Coefficient | 1-3 months between 2 specimen collections | Kappa comparing clinician-collected cytology result to self-lavage cytology result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome: Acceptability of Device | 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 |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample) | 198 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not self-lavage | 1 |
| Overall Study | Lost to Follow-up | 28 |
| Overall Study | Unsatisfactory colposcopy | 2 |
Baseline characteristics
| Characteristic | Single Arm Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 195 Participants |
| Age, Continuous | 34.6 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 198 participants |
| Sex: Female, Male Female | 198 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 198 |
| serious Total, serious adverse events | 0 / 198 |
Outcome results
Primary
Kappa Coefficient
Kappa comparing clinician-collected cytology result to self-lavage cytology result
Time frame: 1-3 months between 2 specimen collections
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm Study of Delphi Screener | Kappa Coefficient | 0.36 kappa coefficient for paired specimens |
Primary
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.
Time frame: 1-3 months between 2 specimen collections
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Study of Delphi Screener | Sensitivity and Specificity | sensitivity | 0.86 % of participants correctly diagnosed |
| Single Arm Study of Delphi Screener | Sensitivity and Specificity | specificity | 0.80 % of participants correctly diagnosed |
Secondary
Outcome: Acceptability of Device
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
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm Study of Delphi Screener | Outcome: Acceptability of Device | 9.6 units on a scale |