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| Name | Class |
|---|---|
| Delphi Devices BV | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delphi Screener | Device | Self-sampling device for cervical vaginal lavage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | cross-sectional - asked at time of Screener use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Westhoff, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Presbyterian Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24376516 | Derived | 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. |
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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.
Recruitment from cervical cancer screening patients from three ambulatory clinics at the New York Presbyterian Hospital from December 1, 2008 to August 31, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | % of participants correctly diagnosed | 1-3 months between 2 specimen collections |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Study | Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heidi Jones | CUNY School of Public Health, Hunter College | 212-396-7750 | hjon@hunter.cuny.edu |
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| ID | Term |
|---|---|
| D000987 | Antisocial Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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 | 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). | Posted | Median | Inter-Quartile Range | units on a scale | cross-sectional - asked at time of Screener use |
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| Primary | Kappa Coefficient | Kappa comparing clinician-collected cytology result to self-lavage cytology result | Posted | Number | 95% Confidence Interval | kappa coefficient for paired specimens | 1-3 months between 2 specimen collections |
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| 0 |
| 198 |
| 0 |
| 198 |
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