Clinical trial · Interventional
Clinician-Collected Versus Patient-Collected Cervical Pap Smears
A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears
NCT01214330CI-TRIAL-00074949SoloPaPcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-Collected Cervical Pap Smear | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient-Collected Cervical Pap Smear
- description
- women will receive a self Papanicolaou Smear test (SoloPap) in addition to their physician-collected Papanicolaou Smear
- interventionNames
- Device: Patient-Collected Cervical Pap Smear
Primary outcomes (1)
- measure
- Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
- timeFrame
- 1 hour
- description
- 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.
Secondary outcomes (1)
- measure
- Patient Opinions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.