Cervical NeoplasiaPhase 2NCT00702208
Feasibility of Delphi Screener for Cervical Cytology
A Phase 2 study testing Delphi Screener in people with Cervical Neoplasia, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Neoplasia
- What is being tested?
- Delphi Screener
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Presbyterian Hospital
New York, New York, 10032
About this study
Official title: The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
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.
- Conditions
- Cervical Neoplasia
- Being tested
- Delphi Screener
- Keywords
- cervical cytology, Pap smear, self-sampling, abnormal, normal
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi ScreenerDevice
Also called Pantarhei Screener, Mermaid
Self-sampling device for cervical vaginal lavage
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Delphi Screener |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-3 months between 2 specimen collections
Kappa Coefficient
Kappa comparing clinician-collected cytology result to self-lavage cytology result
Measured: 1-3 months between 2 specimen collections
Secondary outcomes (1)
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
Measured: cross-sectional - asked at time of Screener use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical NeoplasiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Delphi Devices BV
- Responsible party
- Principal investigator, Carolyn L. Westhoff, Columbia University
- Investigators
- Carolyn Westhoff, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702208
- Sponsor's protocol ID
- AAAD1382
- Status last verified
- Jul 2013
- First submitted
- 30 May 2008
- Last updated
- 13 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24376516
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
- ClinicalTrials.gov ID
- NCT00702208
- Acronym / sponsor ID
- AAAD1382
- Conditions
- Cervical Neoplasia
- Keywords
- cervical cytology, Pap smear, self-sampling, abnormal, normal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Delphi Devices BV
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 13 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Device: Delphi ScreenerPaired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi ScreenerAlso: Pantarhei Screener, MermaidSelf-sampling device for cervical vaginal lavage | Device | Single arm study |
Primary outcome
Sensitivity and Specificity
Time frame: 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
Time frame: 1-3 months between 2 specimen collections
Kappa comparing clinician-collected cytology result to self-lavage cytology result
1 secondary outcome
Outcome: Acceptability of Device
Time frame: cross-sectional - asked at time of Screener use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24376516Jones 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Westhoff, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delphi Screener in people with Cervical Neoplasia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: 1-3 months between 2 specimen collections). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.