Trial Outcomes & Findings for Clinician-Collected Versus Patient-Collected Cervical Pap Smears (NCT NCT01214330)
NCT ID: NCT01214330
Last Updated: 2024-03-12
Results Overview
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.
COMPLETED
NA
150 participants
1 hour
2024-03-12
Participant Flow
150 females, age \>18, without severe hand arthritis were recruited at the Mike O'Callaghan Military Medical Center (formerly Mike O'Callaghan Federal Hospital). The first participant was enrolled January 19, 2011 and the last patient enrolled was September 1, 2011.
Of the 150 participants enrolled, 146 participants received all study interventions (comparison of a self-collected Pap smear with Physician-collected samples).
Participant milestones
| Measure |
Self Pap Smear and Physician Collected Pap Smear
(solopap) self-collected Pap smear and Physician-collected samples.
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
146
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Self Pap Smear and Physician Collected Pap Smear
(solopap) self-collected Pap smear and Physician-collected samples.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Clinician-Collected Versus Patient-Collected Cervical Pap Smears
Baseline characteristics by cohort
| Measure |
Solopap and Physician-collected Pap Smear
n=146 Participants
females, age \>18, without severe hand arthritis
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
146 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourwhether 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.
Outcome measures
| Measure |
Self Pap Smear and Physician Collected Pap Smear
n=102 Participants
(solopap) self-collected Pap smear and Physician-collected samples.
|
|---|---|
|
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
positive+positve
|
8 Participants
|
|
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
negative+negative
|
89 Participants
|
|
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
positive MD + negative solo
|
2 Participants
|
|
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
positive solo+negative MD
|
3 Participants
|
SECONDARY outcome
Timeframe: Directly after interventions (Solo Pap and physician-collected pap smear samples)Population: 146 females recruited from an outpatient clinic in a military treatment facility, age \>18, without severe hand arthritis who completed both the Solo Pap and physician-collected pap smear.
Results from a survey about simple subject attitudes regarding the SoloPap. Patient Solo Pap Kit Questions 1. Did you experience any discomfort while using the Solo Pap Kit? Yes / No 2. Would you use the Solo Pap Kit for future Pap Tests? Yes / No 3. Would you recommend the Solo Pap Kit to a friend or family member? Yes / No
Outcome measures
| Measure |
Self Pap Smear and Physician Collected Pap Smear
n=146 Participants
(solopap) self-collected Pap smear and Physician-collected samples.
|
|---|---|
|
Patient Opinions
discomfort while using solopap · yes
|
36 Participants
|
|
Patient Opinions
discomfort while using solopap · no
|
65 Participants
|
|
Patient Opinions
discomfort while using solopap · no response
|
45 Participants
|
|
Patient Opinions
use solopap in future · yes
|
91 Participants
|
|
Patient Opinions
use solopap in future · no
|
11 Participants
|
|
Patient Opinions
use solopap in future · no response
|
44 Participants
|
|
Patient Opinions
recommend solopap · yes
|
97 Participants
|
|
Patient Opinions
recommend solopap · no
|
4 Participants
|
|
Patient Opinions
recommend solopap · no response
|
45 Participants
|
Adverse Events
Self Pap Smear
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amanda Crawford
Mike O'Callaghan Military Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place