Self-Collected Pap Smear for Cervical Cancer Screening
(Pap Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byJohn B Waits, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Cervical cancer, Positive Pap, Hysterectomy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Self-Collected Pap Smear for Cervical Cancer Screening?
The research indicates that the Pap smear, including self-collected versions, is effective in identifying abnormal cervical cells, such as atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (LSIL), which are important for early detection and management of potential cervical cancer.
12345Is the self-collected Pap smear generally safe for humans?
The research articles do not provide specific safety data for self-collected Pap smears, but traditional Pap smears are widely used and considered safe for cervical cancer screening.
24567How does the Self-Collected Pap Smear treatment differ from traditional cervical cancer screening methods?
The Self-Collected Pap Smear allows women to collect their own cervical cell samples at home, which can increase participation in cervical cancer screening by making it more convenient and less invasive compared to traditional methods where a healthcare provider collects the sample.
5891011Eligibility Criteria
This trial is for women aged 21-65 in rural Alabama who are due for routine cervical cancer screening. It's not open to those with a history of cervical cancer, a positive Pap smear result, those who've had their uterus and cervix removed, or anyone in another cancer prevention study.Inclusion Criteria
I am a woman aged 21-65 needing a routine cervical cancer screening.
Exclusion Criteria
Currently enrolled in any other cancer prevention study.
Positive Pap smear
I have had my uterus and cervix removed.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Self-Collection and Traditional Pap Smear
Participants will self-administer a Pap smear and also have a traditional Pap smear collected by a healthcare provider. Specimens will be blinded and sent for analysis.
1 day
1 visit (in-person)
Analysis and Notification
Specimens are analyzed for accuracy and participants are notified of the results.
2-4 weeks
Follow-up
Participants are monitored for any further necessary actions based on Pap smear results.
4 weeks
Participant Groups
The study is comparing the effectiveness of self-administered Pap smears (Self-PAP) versus traditional Pap smears done by healthcare providers to see if they're equally accurate for cervical cancer screening.
2Treatment groups
Experimental Treatment
Group I: Traditional PapExperimental Treatment1 Intervention
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.
Group II: Self-PAPExperimental Treatment1 Intervention
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.
Self-PAP is already approved in United States, Australia, European Union for the following indications:
🇺🇸 Approved in United States as Self-Collected Pap Test for:
- Cervical Cancer Screening
🇦🇺 Approved in Australia as Self-Collected Pap Test for:
- Cervical Cancer Screening
🇪🇺 Approved in European Union as Self-Collected Pap Test for:
- Cervical Cancer Screening
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cahaba Medical Care - West EndBirmingham, AL
Cahaba Medical CareCentreville, AL
Cahaba Medical Care - EnsleyBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
Laboratory Corporation of AmericaIndustry Sponsor
Cahaba Medical Care FoundationCollaborator
References
Triage of women with ASCUS and LSIL on Pap smear reports: management by repeat Pap smear, HPV DNA testing, or colposcopy? [2022]The purpose of this study was to determine the efficacy of a repeat Papanicolaou (Pap) smear and the Hybrid Capture tube-based (HCT) HPV DNA test for detecting cervical intraepithelial neoplasia (CIN) grade 2 or 3 in women with recent atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) Pap smear reports.
The Bethesda system and evaluation of abnormal pap smears. [2019]The Bethesda Pap Smear system and its 1991 revisions aim to simplify Papanicolaou (Pap) smear reporting and make it more reproducible. It redefines the Pap smear request as a medical consultation. The pathologist consultant is required not only to provide the smear reading but also its clinical recommendation. The Bethesda system insists on a detailed Pap smear report assessing specimen adequacy and types of epithelial changes. Squamous cell abnormalities are grouped according to their biologic potential. Both cervical intraepithelial neoplasia, grade I (CIN I) (mild dysplasia) and human papillomavirus (HPV) lesions are grouped together as low-grade squamous intraepithelial lesions (LGSIL), while moderate and severe dysplasia (CIN II and III) belong to the high-grade squamous intraepithelial lesion (HGSIL) category. Atypical squamous cells of undetermined significance (ASCUS) and atypical glandular cells of undetermined significance (AGCUS) need further qualification as to whether they favor either a reactive or neoplastic process. Guidelines for management of abnormal Pap smears are discussed in detail.
World wide web-based cytological analysis of atypical squamous cells cannot exclude high-grade intraepithelial lesions. [2022]It has been reported that the low level of consistency of diagnosis of atypical squamous cells cannot exclude high-grade squamous intraepithelial lesions (ASC-H) in uterine cervical cancer screening using the Bethesda System, indicating the necessity of a large-scale survey. We presented cases cytologically judged as ASC-H on our website and invited our members to give their opinions regarding the diagnosis by voting online. The Web voting results were analyzed and ASC-H was cytologically investigated.
Management of atypical squamous cells of undetermined significance and low-grade squamous intra-epithelial lesion by human papillomavirus testing. [2022]Cervical cytological terminology varies from country to country. In the USA, the Pap smear is reported using the Bethesda system. The abnormal morphological changes described by this system include two very problematic categories: atypical squamous cells of undetermined significance (ASCUS) and atypical glandular cells of undetermined significance (AGUS). The management of ASCUS, which is similar to the British system 'borderline' smear, has been most problematic because the majority of women with this Pap result are normal, although approximately 5-11% have high-grade cervical intraepithelial neoplasia and 1 per 1000 has cervical cancer. Because AGUS is far less common and a significantly greater risk for high-grade cervical intraepithelial neoplasia, adenocarcinoma in situ and cancer, its management is far less controversial, but it is problematic because of clinical confusion with the ASCUS terminology. Low-grade squamous intraepithelial neoplasia is almost entirely related to human papillomavirus. Documentation that certain high-risk types of human papillomavirus are necessary in the aetiology of cervical cancer has led to investigations into the management of these equivocal and low-grade Pap smear abnormalities by testing for these human papillomavirus types.
Atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) and histology. [2022]A new terminology for cytologic diagnosis of cervical lesions has been introduced by Bethesda System. This includes: 1) Atypical squamous cells of undetermined significance (ASCUS), 2) Low-grade squamous intraepithelial lesion (LSIL), 3) High-grade squamous intraepithelial lesion (HSIL), 4) squamo-cellular carcinoma. The aim of this study was to assess the correlation between the colpocytologic test (Pap psmear), the histologic response and colposcopy.
[Verification of doubtful PAP smear results of women included in the screening program in the Podlaskie province]. [2022]Verification of uncertain PAP-smear results in a group of women covered by the cervical screening program in the Podlaski province. The main aim of the study was to identify CIN (Cervical Intraepithelial Neoplasia) lesions present, with varying degrees of severity in women with cytological diagnosis of ASCUS (atypical squamous cells of undetermined significance), LSIL (low grade squamous intraepithelial lesion), and ASC-H (atypical squamous cells - cannot exclude high grade squamous intraepithelial lesion).
Role of Pap Test terminology and age in the detection of carcinoma invasive and carcinoma in situ in medically underserved California women. [2022]Our goals were to evaluate Pap Test findings classified by the Bethesda system, and follow up biopsies from participants in the California Breast and Cervical Cancer Control Program (Ca-BCCCP) for: 1) correlation in the detection of carcinoma in situ (CIS) and carcinoma invasive (CI), and 2) age-related trends, with discussion in the context of the 2001 ASCCP Management Guidelines. Women (n = 52,339) who had their initial screening Pap Tests with Ca-BCCCP between January 1995-December 1999 were followed for diagnostic services through December 2000. Descriptive and analytical methods were used in the analysis. Of the Pap results, 81.9% were negative, 10.6% showed infection, 4.7% showed an epithelial abnormality as defined by the Bethesda system (atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL)), 0.1% showed squamous-cell cancer (SCC), and 2.7% showed other or unsatisfactory. Subsequent to the initial Pap Test, follow-up results of carcinoma in situ (CIS) and carcinoma invasive (CI) accounted for 0.36% and 0.05% of the population, respectively. Among HSIL Pap Tests (n = 285), 40.7% had follow-up showing CIS. Among SCC Pap Tests, 17.9% had follow-up results of CIS and 28.6% CI. Of the 191 patients with CIS as a follow-up finding, the initial Pap smear showed: HSIL 60.7%, SCC 2.6%, LSIL 10.5%, ASCUS 13.6%, and negative or infection 9.9%. Of the 27 patients with CI, the initial Pap Test showed: HSIL 40.7%, SCC 29.6%, LSIL 7.4%, ASCUS 7.4%, and negative or infection 11.1%. Pap diagnoses of other or unsatisfactory accounted for 2.6% of the Pap results from patients with CIS and 3.7% of Pap results from patients with CI. Except for LSIL, there was an increasing age trend in the number of cases in each of Pap results, with the exception of age 65+ yr. However, the ratio of LSIL and ASCUS to negative cases decreased with age. (P
Self-Collected Samples in Cervical Cancer Screening: Results of HPV and Pap Self-Collected Samples Compared to Physician-Obtained Specimens. [2022]In order to increase overall participation in cervical cancer screening, several investigators propose a concept of introducing self-tests. The study presented here compared test results of the Pap test and 4 different HPV test systems of self-collected and physician-collected vaginal specimens.
Evaluation of atypical and low-grade cervical cytology in private practice. [2022]To evaluate the adequacy of cytology alone for diagnosis of grade of cervical intraepithelial neoplasia (CIN) and to study performance of cytology, human papillomavirus (HPV) testing, and colposcopy in the evaluation of cytologic findings suggesting low-grade squamous intraepithelial lesions (SIL), or atypical squamous (ASCUS) or atypical glandular (AGCUS) cells of undetermined significance.
Biopsy-based comparison of liquid-based, thin-layer preparations to conventional Pap smears. [2022]To evaluate and compare histologic diagnosis of squamous intraepithelial neoplasia and cancer of the cervix with cytologic diagnosis using the conventional Pap smear versus the AutoCyte PREP liquid-based, thin-layer preparation.
High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. [2019]A user-friendly self-sampling method for collecting representative cervical cell material would lower the threshold for women to respond to the invitation for cervical screening. In the present article, we introduce such a device; we have evaluated its sensitivity and specificity to detect high-grade cervical intraepithelial neoplasia (CIN), via high-risk human papillomavirus (hrHPV) detection and liquid-based cytology (LBC), compared to endocervical brush samples obtained by gynecologists. Women who had a cervical smear reading of moderate dyskaryosis or worse or a repeat equivocal Pap smear result in the cervical screening program (n=64) and healthy volunteers (n=32) took a self-obtained sample at home prior to their visit to the gynecological outpatient department. At the outpatient department, an endocervical brush smear was taken, followed by colposcopy and biopsy whenever applicable. Both self-obtained samples and endocervical brush samples were immediately collected in Surepath preservation solution and used for LBC and hrHPV testing (by general primer-mediated GP5+/6+PCR). hrHPV test results showed a good concordance between the two sample types (87%; kappa=0.71), with sensitivities for prevalent high-grade CIN that did not differ significantly (92% and 95%; P=1.0). The hrHPV test on self-obtained samples proved to be at least as sensitive for high-grade CIN as cytology on endocervical brush samples (34/37 versus 31/37; P=0.5). LBC showed a poor concordance between self-obtained and endocervical brush samples (60%; kappa=0.27). In conclusion, self-obtained samples taken by this novel device are highly representative of the hrHPV status of the cervix. In combination with hrHPV testing, the use of this device may have implications for increasing the attendance rate for cervical screening programs.