The power of the biomarker for cervical cancer control

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 11001-11001
Author(s):  
N. S. Markovic ◽  
O. Markovic ◽  
E. S. Henderson
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Pap Smear ◽  
Digital Images ◽  
Papanicolaou Test ◽  
New Device ◽  
Comparison Results ◽  
Digital Evaluation ◽  
In Vitro Diagnostic

11001 Background: At ASCO 2001, the Cervical Acid Phosphatase - Papanicolaou Test (CPT) was introduced as a biomarker-based technology as a potential in vitro diagnostic device. At ASCO 2004 and 2005, we reported results from clinical trials on 2,000 subject/specimens. In a setting of standard cervical cancer screening, the safety and effectiveness of CPT (MarkPap® Test) was compared with control Pap smear and LBP. The favorable results motivated us to expand this translational research in areas where this biomarker is crucial: self-sampling and digital evaluation. We report a pilot study designed to assess whether upgrading CPT with digital image processing (IT technology) could create a new device for an effective telecytopathology. Methods: Material: Cervical specimens self-obtained by volunteers, specimens collected in prior clinical trials (Library of MarkPap slides), and control slides. Instruments and methods: We have assembled a set of instruments and procedures to create images from microscopic slides, to convert analog into digital images, to capture and store digital images and clinical data in computer files, to transfer image files via Internet to a central server for evaluation by cytotechnologist/pathologists, and to return the reports within hours. At the end, the results of reading digital and direct images were available for comparison. Results: Since each instrument was “fit-for-use”, we have tested different “conditions-for-use” for providing digital images comparable to direct images. Images of self-sampled specimens, controls and existing slides were processed through a new setup of five modules: image acquisition, image and data transferring, image evaluation, results reporting and quality control. It was made possible by upgrading software. There was no difference between results obtained after evaluation of digital or direct images. Conclusion: Using CPT and available instruments and software, we have developed a prototype in vitro diagnostic medical device, which could permit expert evaluation of cervical specimens to be performed rapidly and at affordable cost for developing countries. This device should be able to use self-obtained specimens, field laboratory personnel and equipment, but to provide high-qualified evaluation within hours for an easy affordable cost. [Table: see text]

scholarly journals US Food and Drug Administration Perspectives on Clinical Mass Spectrometry

2016 ◽  
Vol 62 (1) ◽  
pp. 41-47 ◽  
Author(s):  
Julia Tait Lathrop ◽  
Douglas A Jeffery ◽  
Yvonne R Shea ◽  
Peter F Scholl ◽  
Maria M Chan
Keyword(s):  
Mass Spectrometry ◽  
Clinical Trials ◽  
Drug Administration ◽  
Review Process ◽  
Food And Drug Administration ◽  
Regulatory Review ◽  
In Vitro Diagnostic ◽  
Guidance Documents ◽  
Proteins And Peptides

Abstract Mass spectrometry–based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry–based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry–based devices and enhance their entry into the clinic.

scholarly journals Utility of Papanicolaou’s smears in the diagnosis of premalignant and malignant lesions of the cervix in a tertiary care centre of South Gujarat, India

2019 ◽  
Vol 7 (9) ◽  
pp. 3342
Author(s):  
Shivangi S. Gandhi ◽  
Pinal C. Shah
Keyword(s):  
Cervical Cancer ◽  
Developing Countries ◽  
Pap Smear ◽  
Early Stage ◽  
Tertiary Care ◽  
Developed Countries ◽  
Pap Smears ◽  
Papanicolaou Test ◽  
Incidence And Mortality ◽  
Malignant Lesions

Background: "Preventable but not prevented", this is the reality of cervical cancer today, at least in developing countries. 80% of all the cases of cervical cancer occur in these developing countries. In India, cervical cancer is the leading cause of cancer related deaths in women. The Papanicolaou test is simple, quick, and painless. It is capable of detecting cervical cancer at an early stage and is used widely in developed countries, where it has decreased both the incidence and mortality of cervical cancer. Objective of the study was conducted to determine the importance of conventional Pap smears for the diagnosis of inflammatory, premalignant and malignant lesions of the cervix.Methods: This cross-sectional study was conducted from January 2017 to June 2018 on 2000 women coming for a Pap smear examination in Government Medical College attached to New Civil Hospital, Surat. After doing Pap stain, all cases were reported as per the 2014 Bethesda system.Results: A total of 2000 cases of Pap smears were received out of which 1914(95.7%) cases were satisfactory for evaluation, 86(4.3%) cases were unsatisfactory. The frequency of epithelial abnormalities was 3.66%. The age group of 51-60 years showed the highest epithelial abnormalities. The frequency of epithelial abnormalities in asymptomatic women was 2.3%. Out of the 1844 cases, 103(5.6%) showed changes of atrophy, 1011(54.8%) cases showed inflammatory/reactive changes, whereas organisms were seen in 558(30.3%) cases.Conclusions: Pap smear happens to be an economical, safe and pragmatic diagnostic tool for early detection of cervical cancer.

scholarly journals Urban Poor Community Settings' Knowledge and Screening Practices for Cervical Cancer in Ibadan, Nigeria

2021 ◽  
pp. 1024-1031
Author(s):  
Yetunde O. John-Akinola ◽  
Mojisola M. Oluwasanu ◽  
Oladimeji Oladepo
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Urban Poor ◽  
Pap Smear ◽  
Human Papillomavirus Vaccine ◽  
Community Settings ◽  
Papanicolaou Test ◽  
Screening Practices ◽  
Papillomavirus Vaccine ◽  
Ibadan Nigeria

PURPOSE This study investigated knowledge and screening practices for cervical cancer among two urban poor community settings in Ibadan, Nigeria. METHODS A cross-sectional design was used. ODK tool was used to collect quantitative data among a sample size of 500 respondents. Data were analyzed using IBM SPSS version 21 for descriptive and inferential statistics. Scores for knowledge were on a scale of 0-39 points (0-18 low, 19-23 fair, and 24-39 high knowledge). RESULTS A majority of respondents (77.2%) had low knowledge of cervical cancer and were not aware (93.6%) of the Papanicolaou test (Pap smear test) or cervical cancer screening (91.2%). Very few women (10%) were aware of the human papillomavirus vaccine for the prevention of cervical cancer, 4% had been screened with the Papanicolaou test, and one woman (0.3%) with visual inspection with acetic acid. Four (1.1%) women had taken human papillomavirus vaccine before. CONCLUSION The findings of this study have underscored a necessity for increased awareness creation through health promotion interventions and strategies to alleviate low knowledge, prevention, and screening practices for cervical cancer in poor community settings in Nigeria.

scholarly journals Informed Consent in Clinical Trials of in Vitro Diagnostic Devices: Perspectives from the FDA and Manufacturers

2001 ◽  
Vol 47 (10) ◽  
pp. 1753-1757
Author(s):  
Marva M Moxey-Mims ◽  
Marian J Serge ◽  
Marsha N Melvin
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
In Vitro Diagnostic

scholarly journals Prevalence and associated risk factors of abnormal pap smear in pregnant women

2019 ◽  
Vol 8 (12) ◽  
pp. 4980
Author(s):  
Neha Mohindroo ◽  
Anoop Sharma ◽  
Santosh Minhas ◽  
Kushla Pathania
Keyword(s):  
Risk Factors ◽  
Cervical Cancer ◽  
Bacterial Vaginosis ◽  
Pregnant Women ◽  
Pap Smear ◽  
Cervical Screening ◽  
Lower Class ◽  
Published Data ◽  
Papanicolaou Test ◽  
Associated Risk Factors

Background: The Papanicolaou test is a method of cervical screening used to detect pre-cancerous and cancerous processes. The incidence of cervical cancer in India is alarmingly high and is the leading cause of cancer in women in India accounting for 147 deaths per lakh women. Cervical cytological abnormalities are found in up to 5% of all pregnancies. In Indian settings, published data on abnormal Pap smear in pregnancy is lacking. The present study was designed to know the prevalence of abnormal Pap smear in pregnant women and its associated risk factors.Methods: This prospective study included 450 pregnant and 450 non-pregnant women who fulfilled the inclusion criteria. After a detailed history, clinical examination and investigations, Pap smear was collected as per conventional method and reported using 2014 Bethesda system.Results: 53.6% pregnant and 44.6% non-pregnant subjects had abnormal Pap smear. Out of the abnormal smears in pregnant women, 31.18% had inflammatory cytology, 15.37% had bacterial vaginosis, 4.01% had Trichomonal and 3.34% Monilial pathology. No epithelial cell abnormality was seen. Rural residence, lower class, age at first intercourse less than 21 years and having more than one sexual partner were important risk factors observed in our study and were statistically significant.Conclusions: Bacterial vaginosis, the most common infection detected on Pap smear is strongly associated with previos preterm labour and delivery. This opportunity for screening of cervical cancer and counselling should not be missed in the antenatal period.

scholarly journals HEALTH SURVEILLANCE AND PAP TEST COVERAGE: INTEGRATIVE REVIEW

2016 ◽  
Vol 25 (4) ◽  
Author(s):  
Janara Caroline Ribeiro ◽  
Selma Regina de Andrade
Keyword(s):  
Cervical Cancer ◽  
Health Promotion ◽  
Pap Smear ◽  
Pap Test ◽  
Health Surveillance ◽  
Integrative Review ◽  
Test Coverage ◽  
Inclusion Criteria ◽  
Papanicolaou Test ◽  
Cervix Neoplasm

ABSTRACT This integrative review aimed to evidence in the literature health surveillance activities that contribute to the increased coverage of the cervical Pap smear. The search was undertaken between April and May 2014 in the databases LILACS, CINAHL, MEDLINE and Scopus, using the keywords health surveillance, cervix neoplasm prevention, and Papanicolaou test, in Portuguese, English and Spanish. We selected 341 articles, of which 33 met the inclusion criteria. In studies, the actions have been identified and grouped according to two main control practices of cervical cancer adopted in Brazil: primary prevention and secondary prevention, with emphasis on health promotion and prevention actions that contributed to the increased coverage of the cervical Pap smear.

A Novel Nucleus Detection on Pap Smear Image Using Mathematical Morphology Approach

2021 ◽  
Vol 49 ◽  
pp. 53-61
Author(s):  
Nadzirah Nahrawi ◽  
Wan Azani Mustafa ◽  
Siti Nurul Aqmariah Mohd Kanafiah ◽  
Wan Khairunizam Wan Ahmad ◽  
Mohamad Nur Khairul Hafizi Rohani ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Mathematical Morphology ◽  
Pap Smear ◽  
Image Quality Assessment ◽  
Median Filter ◽  
Correct Diagnosis ◽  
Conventional Technique ◽  
Papanicolaou Test ◽  
Pap Smear Test ◽  
Contrast Stretching

The fourth most common form of cancer among women is cervical cancer with 569,847new cases and 311,365 reported deaths worldwide in 2018. Cervical cancer is classified as the third leading cause of cancer among women in Malaysia, with approximately 1,682 new cervical cases and about 944 deaths occurred in 2018. Cervical cancer can be detected early by cervical cancer screening. Papanicolaou test, also known as Pap smear test is conducted to detect cancer or precancer in the cervix. The disadvantage of this conventional method is that the sample of microscopic images will risk blurring effects, noise, shadow, lighting and artefact problems. The diagnostic microscopic observation performed by a microbiologist is normally time-consuming and may produce inaccurate results even by experienced hands. Thus, correct diagnosis information is essential to assist physicians to analyze the condition of the patients. In this study, an automatedsegmentation system is proposed to be used as it is more accurate and faster compared to the conventional technique. Using the proposed method in this paper, the image was enhanced by applying a median filter and Partial Contrast Stretching. A segmentation method based on mathematical morphology was performed to segment the nucleus in the Pap smear images. Image Quality Assessment (IQA) which measures the accuracy, sensitivity and specificity were used to prove the effectiveness of the proposed method. The results of the numerical simulation indicate that the proposed method shows a higher percentage of accuracy and specificity with 93.66% and 95.54% respectively compared to Otsu, Niblack and Wolf methods. As a conclusion, the percentage of sensitivity is slightly lower, with 89.20% compared to Otsu and Wolf methods. The results presented here may facilitate improvements in the detection performance in comparison to the existing methods.

scholarly journals ThinPrep Pap Test for Diagnosis of Cervical Cancer in Early Stages

2019 ◽  
Vol 4 (4) ◽  
pp. 141-144
Author(s):  
Siamak Sabour ◽  
Ommolbanin Abbasnezhad ◽  
Ali Dastranj Tabrizi ◽  
Amir Vahedi ◽  
Elmira Mostafidi
Keyword(s):  
Cervical Cancer ◽  
Screening Test ◽  
Pap Smear ◽  
Pap Test ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
Papanicolaou Test ◽  
Observer Reliability ◽  
Early Stages ◽  
Intraepithelial Lesion

Background: Cervical cancer is one of the world’s deadliest forms of cancer and Pap smear is the most popular screening test for diagnosis in early stages. The aim of our study was to assess potential screening rule of ThinPrep Pap test. Methods: In this cross sectional, study Cervical samples were collected from all women who referred to a pathology center for Papanicolaou test and all samples were prepared with ThinPrep process. To assess validity, biopsy was selected as gold standard. 131 women who had ThinPrep Pap test and biopsy were considered for the analysis. The participants were selected purposeful. Three thresholds were used to define test positivity: 1) Atypical squamous cells of undetermined significance (Asc-us) 2) Low grade squamous intraepithelial lesion (LSIL) 3) High grade squamous intraepithelial lesion (HSIL) and worse. Inter and intra observer reliability were evaluated using kappa (simple and weighted) as well as Fleiss kappa and validity were assessed by the well-known validity estimates for qualitative variables. Results: Intra observer reliability was moderate for pathologists with low and moderate experience (kappa was 0.44 and 0.46 respectively) and was good for experienced pathologist [kappa (WK) = 0.64]; however, inter observer reliability was poor (Fliess kappa=0.12). For diagnosis of ASCUS and worse, the sensitivity was 96.3% and for diagnosis of HSIL and worse the sensitivity and specificity were 86.6% and 95.1%, respectively.Conclusion: ThinPrep pap is an acceptable screening test for diagnosis of cervical cancer in early stages. However, experience and specialty have effect on reliability’s results.

Effect of Health Education About Cervical Cancer and Papanicolaou Testing on the Behavior, Knowledge, and Beliefs of Turkish Women

2012 ◽  
Vol 22 (8) ◽  
pp. 1407-1412 ◽  
Author(s):  
Hatice Bebis ◽  
Nesrin Reis ◽  
Tulay Yavan ◽  
Damla Bayrak ◽  
Ayşe Unal ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Test Score ◽  
Pap Smear ◽  
Health Belief ◽  
Control Group ◽  
Study Group ◽  
Papanicolaou Test ◽  
Pap Smear Test ◽  
Knowledge And Beliefs ◽  
Belief Model

BackgroundCervical cancer is the second most common form of cancer observed among women in Turkey. The participation of women in cervical cancer screening programs is strongly affected by Turkish attitudes, beliefs, and sociocultural structure.AimThis study was conducted to assess the effectiveness of health education that aimed to raise awareness about Papanicolaou testing and to emphasize the importance of the early diagnosis of cervical cancer.Materials and MethodsThe study was conducted as a prospective, randomized, controlled trial and was carried out in 148 women. Seventy-five women in the control group were asked to fill out questionnaire forms. A 45-minute conference-style training was given to 73 women in the study group, and all of the subjects were asked to fill out the forms after the training. The sociodemographic characteristics of the 2 groups and the mean “Health Belief Model Scale for Cervical Cancer and Pap Smear Test” scores of the 2 groups were statistically analyzed by Statistical Package of Social Sciences (SPSS), version 15.ResultsThere was no statistically significant difference noticed between the sociodemographic characteristics of the 2 groups (P> 0.05). The difference in test scores, which represented knowledge about cervical cancer and Papanicolaou testing, was statistically significant between the control group and the study group (t= 10.122,P< 0.05). In the Health Belief Model Scale for Cervical Cancer and Pap Smear Test, there were statistically significant differences in the following measures: lower levels of susceptibility to cervical cancer score (t= −2.035,P< 0.05), lower levels of perceived benefit from a Papanicolaou test score (t= 3.278,P< 0.05) and lower levels of perceived barriers to Papanicolaou test score (t= −3.182,P< 0.05).ConclusionNurses should be involved in educating women about cervical cancer and Papanicolaou testing. By doing so, they can change the attitudes, knowledge, and beliefs of the women.

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