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NCT04093388 Clinical Trial

Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama

Cervical Cancer Clinical Trial

— Pap  

Official title:
Self-Collection of the Pap Smear as Agency: A Novel Way to Improve Refractory Low Cervical Cancer Screening Rates in Rural Alabama

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04093388
Other study ID # IRB-300002819
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2021
Est. completion date August 30, 2025

Study information
Verified date April 2024
Source University of Alabama at Birmingham
Contact John B Waits, MD
Phone 2052772379
Email john.waits@cahabamedicalcare.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date August 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Self-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.
• Traditional 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.

Locations
Country Name City State
United States Cahaba Medical Care - Ensley Birmingham Alabama
United States Cahaba Medical Care - West End Birmingham Alabama
United States Cahaba Medical Care Centreville Alabama

Sponsors (3)
Lead Sponsor Collaborator
University of Alabama at Birmingham Cahaba Medical Care Foundation, Laboratory Corporation of America

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2018 Dec 4;320(21):2273. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the self-PAP against the traditional Pap smear procedure Baseline through 14 days
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