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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-300002819 | Other Grant/Funding Number | UAB |
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| Name | Class |
|---|---|
| Cahaba Medical Care Foundation | OTHER |
| Laboratory Corporation of America | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-PAP | Experimental | Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the self-administered Papanicolaou (Pap) smear. They will be compared to each other for congruence and accuracy. |
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| Traditional Pap | Experimental | Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the traditional, healthcare provider obtained Papanicolaou (Pap) smear specimen. They will be compared to each other for congruence and accuracy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-PAP | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the self-PAP against the traditional Pap smear procedure | Baseline through 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John B Waits, MD | Contact | 2052772379 | john.waits@cahabamedicalcare.com | |
| Lacy Smith, PhD | Contact | 2053378726 | lacy.smith@cahabamedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| John B Waits, MD | PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Medical Care - West End | Recruiting | Birmingham | Alabama | 35211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27647799 | Background | Chen K, Ouyang Y, Hillemanns P, Jentschke M. Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. J Obstet Gynaecol Res. 2016 Dec;42(12):1839-1845. doi: 10.1111/jog.13132. Epub 2016 Sep 20. | |
| 18708409 | Background |
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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.
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Pathologist (outcomes assessor) will be blinded
|
| Traditional Pap smear | Diagnostic Test | 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. |
|
| Cahaba Medical Care - Ensley | Recruiting | Birmingham | Alabama | 35218 | United States |
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| Cahaba Medical Care | Recruiting | Centreville | Alabama | 35042 | United States |
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| De Alba I, Anton-Culver H, Hubbell FA, Ziogas A, Hess JR, Bracho A, Arias C, Manetta A. Self-sampling for human papillomavirus in a community setting: feasibility in Hispanic women. Cancer Epidemiol Biomarkers Prev. 2008 Aug;17(8):2163-8. doi: 10.1158/1055-9965.EPI-07-2935. |
| 12518778 | Background | Chang CC, Tseng CJ, Liu WW, Jain S, Horng SG, Soong YK, Hsueh S, Pao CC. Clinical evaluation of a new model of self-obtained method for the assessment of genital human papilloma virus infection in an underserved population. Chang Gung Med J. 2002 Oct;25(10):664-71. |
| 25247320 | Background | Haguenoer K, Sengchanh S, Gaudy-Graffin C, Boyard J, Fontenay R, Marret H, Goudeau A, Pigneaux de Laroche N, Rusch E, Giraudeau B. Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial. Br J Cancer. 2014 Nov 25;111(11):2187-96. doi: 10.1038/bjc.2014.510. Epub 2014 Sep 23. |
| 27703293 | Background | Jahic M, Jahic E. Diagnostic Approach to Patients with Atypical Squamous Cells of Undetermined Significance Cytologic Findings on Cervix. Med Arch. 2016 Jul 27;70(4):296-298. doi: 10.5455/medarh.2016.70.296-298. |
| 28086983 | Background | Kobetz E, Seay J, Amofah A, Pierre L, Bispo JB, Trevil D, Gonzalez M, Poitevien M, Koru-Sengul T, Carrasquillo O. Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial. Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6. |
| 10632284 | Background | Wright TC Jr, Denny L, Kuhn L, Pollack A, Lorincz A. HPV DNA testing of self-collected vaginal samples compared with cytologic screening to detect cervical cancer. JAMA. 2000 Jan 5;283(1):81-6. doi: 10.1001/jama.283.1.81. |
| 25171269 | Background | Labani S, Asthana S. Human papillomavirus viral load on careHPV testing of self-collected vaginal samples vs. clinician-collected cervical samples. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:233-9. doi: 10.1016/j.ejogrb.2014.08.005. Epub 2014 Aug 13. |
| 29971397 | Background | Ogilvie GS, van Niekerk D, Krajden M, Smith LW, Cook D, Gondara L, Ceballos K, Quinlan D, Lee M, Martin RE, Gentile L, Peacock S, Stuart GCE, Franco EL, Coldman AJ. Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial. JAMA. 2018 Jul 3;320(1):43-52. doi: 10.1001/jama.2018.7464. |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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