Cervical Cancer Screening
Conditions
Keywords
Pap Smear Collection
Brief summary
This research study is comparing Pap smear collection techniques using the Papette brush to traditional spatula and cytology brush for cervical cancer screening
Detailed description
At the investigators institution the investigators have been using both the traditional spatula and cytology and the Papette brush for Pap smear collection. The investigators will be comparing adequacy of sample rates, provider perceived pain and bleeding and overall satisfaction with each collection technique.
Interventions
DIAGNOSTIC_TESTPapette brush collection
Cervical cell brush that gathers collects cervical cells during Pap smear collection
DIAGNOSTIC_TESTSpatula/cytology brush collection
Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult women, aged 21-64 years old. * Have given consent for medical records to be accessed. * Who will have a Pap smear exam in CIM from July 2021 through June 2022.
Exclusion criteria
* Women, age \< 21 or \> 64. * Has vaginal spotting present during cervical sampling. * Did not give consent to have medical records accessed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specimen Adequacy | Baseline | Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Bleeding With Collection | Baseline | Number of subjects to experience bleeding with collection of samples during the Pap smear exam |
| Collection Time | Baseline | The amount of time it takes to collect a sample measured in seconds |
| Perceived Pain | Baseline | Provider-reported survey to assess patient perceived pain for Papette brush compare to spatula/cytology bush technic as more, the same, or less patient perceived pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pap Smears Using the Papette Papette brush used to collect a Pap smear sample as standard of care.
Papette brush collection: Cervical cell brush that gathers collects cervical cells during Pap smear collection | 357 |
| Pap Smears Using the Traditional Spatula/Cytology Brush Spatula/cytology brush used to collect a Pap smear sample as standard of care.
Spatula/cytology brush collection: Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection | 399 |
| Total | 756 |
Baseline characteristics
| Characteristic | Pap Smears Using the Papette | Pap Smears Using the Traditional Spatula/Cytology Brush | Total |
|---|---|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 13.64 | 46.8 years STANDARD_DEVIATION 12.34 | 45.4 years STANDARD_DEVIATION 13.04 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 17 Participants | 28 Participants | 45 Participants |
| Race/Ethnicity, Customized Black or African American | 13 Participants | 16 Participants | 29 Participants |
| Race/Ethnicity, Customized Other | 17 Participants | 16 Participants | 33 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 309 Participants | 334 Participants | 643 Participants |
| Region of Enrollment United States | 357 participants | 399 participants | 756 participants |
| Sex: Female, Male Female | 357 Participants | 399 Participants | 756 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 357 | 0 / 399 |
| other Total, other adverse events | 0 / 357 | 0 / 399 |
| serious Total, serious adverse events | 0 / 357 | 0 / 399 |
Outcome results
Primary
Specimen Adequacy
Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pap Smears Using the Papette | Specimen Adequacy | 335 Participants |
| Pap Smears Using the Traditional Spatula/Cytology Brush | Specimen Adequacy | 371 Participants |
p-value: 0.75Chi-squared
Secondary
Cervical Bleeding With Collection
Number of subjects to experience bleeding with collection of samples during the Pap smear exam
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pap Smears Using the Papette | Cervical Bleeding With Collection | 0 Participants |
| Pap Smears Using the Traditional Spatula/Cytology Brush | Cervical Bleeding With Collection | 0 Participants |
Secondary
Collection Time
The amount of time it takes to collect a sample measured in seconds
Time frame: Baseline
Population: Data was not collected or analyzed for this outcome measure
Secondary
Perceived Pain
Provider-reported survey to assess patient perceived pain for Papette brush compare to spatula/cytology bush technic as more, the same, or less patient perceived pain.
Time frame: Baseline
Population: Data was not collected nor analyzed