Cervical CancerSoloPaPNCT01214330
Clinician-Collected Versus Patient-Collected Cervical Pap Smears
A study testing Patient-Collected Cervical Pap Smear in people with Cervical Cancer, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial summary
The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females. 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 Cancer
- What is being tested?
- Patient-Collected Cervical Pap Smear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- 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
- Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
- All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding
Who cannot join
- Age <18 years (not recommended for Pap Smear)
- Known pregnancy
- Women who have had a total hysterectomy (cervix removed)
- Women with vaginal bleeding
- Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Las Vegas, Nevada, 89191
About this study
Official title: A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears
The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.
Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.
Read the detailed description
The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.
- Conditions
- Cervical Cancer
- Being tested
- Patient-Collected Cervical Pap Smear
- Keywords
- cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Collected Cervical Pap SmearDevice
Also called SoloPap
Patient-Collected Cervical Papanicolaou Smear
| Study group | Role | What they receive |
|---|---|---|
| Patient-Collected Cervical Pap Smear | Experimental | women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear Receives: Device: Patient-Collected Cervical Pap Smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
whether the SoloPap™ cervical cell sample collection kit used by the subject (patient) is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.
Measured: 1 hour
Secondary outcomes (1)
Patient Opinions
Results from a survey about simple subject attitudes regarding the SoloPap.
Patient Solo Pap Kit Questions
- Did you experience any discomfort while using the Solo Pap Kit? Yes / No
- Would you use the Solo Pap Kit for future Pap Tests? Yes / No
- Would you recommend the Solo Pap Kit to a friend or family member? Yes / No
Measured: Directly after interventions (Solo Pap and physician-collected pap smear samples)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
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.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul Crawford, M.D., Principal investigator, Mke O'Callaghan Federal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214330
- Sponsor's protocol ID
- FWH20100177H
- Acronym
- SoloPaP
- Status last verified
- Feb 2024
- First submitted
- 30 Sep 2010
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears
- ClinicalTrials.gov ID
- NCT01214330
- Acronym / sponsor ID
- SoloPaP / FWH20100177H
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.
Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.
Detailed description
The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient-Collected Cervical Pap Smear | Experimental | Device: Patient-Collected Cervical Pap Smearwomen will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
- All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding
Key exclusion criteria (5 listed)
- Age <18 years (not recommended for Pap Smear)
- Known pregnancy
- Women who have had a total hysterectomy (cervix removed)
- Women with vaginal bleeding
- Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands
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 |
|---|---|---|
| Patient-Collected Cervical Pap SmearAlso: SoloPapPatient-Collected Cervical Papanicolaou Smear | Device | Patient-Collected Cervical Pap Smear |
Primary outcome
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
Time frame: 1 hour
whether the SoloPap™ cervical cell sample collection kit used by the subject (patient) is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.
1 secondary outcome
Patient Opinions
Time frame: Directly after interventions (Solo Pap and physician-collected pap smear samples)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Crawford, M.D. principal investigator
Mke O'Callaghan Federal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Collected Cervical Pap Smear in people with Cervical Cancer, run by Mike O'Callaghan Military Hospital 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 2 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 12 Mar 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 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?
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.