Cervical Cancer
Conditions
Keywords
Pap smear, Papanicolaou, self-collection, cervical cancer screening
Brief summary
The purpose of the study is to find out if a self-administered (by the patient) Papanicolaou (Pap) smear is as accurate as a traditional Pap smear administered by a healthcare provider.
Detailed description
Papanicolaou (Pap) smears will be both self-obtained by the patient and obtained by a licensed physician, nurse practitioner, or physician assistant. Specimens will then be collected by the nurse or medical assistant who will label each specimen separately. Specimens will be blinded so that the pathologist will not know which specimen was self-collected and which provider-collected. Specimens will then be sent to our clinical laboratory provider (LabCorp) for analysis. Once results from the Pap smears are received, participants will be notified in the usual manner in our clinical practice. Finally, analysis will be conducted to ascertain whether or not a self-administered (by the patient) Pap smear is as accurate as a traditional Pap smear administered by a healthcare provider.
Interventions
DIAGNOSTIC_TESTSelf-PAP
A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.
DIAGNOSTIC_TESTTraditional Pap smear
A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.
Sponsors
University of Alabama at Birmingham
Cahaba Medical Care Foundation
Laboratory Corporation of America
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Pathologist (outcomes assessor) will be blinded
Intervention model description
A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female of at least 21 years of age and not over 65 presenting who need routine cervical cancer screening per national guidelines.
Exclusion criteria
* prior history of cervical cancer or a positive Pap smear, have had a total hysterectomy (removal of uterus and cervix), or currently enrolled in any other cancer prevention study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the self-PAP against the traditional Pap smear procedure | Baseline through 14 days |
Countries
United States
Contacts
CONTACTJohn B Waits, MD
CONTACTLacy Smith, PhD
PRINCIPAL_INVESTIGATORJohn B Waits, MD
PI
Outcome results
None listed