RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
ANNEXURE II
SYNOPSIS FOR REGISTRATION OF SUBJECT FOR
DISSERTATION
1 / NAME OF THE CANDIDATE/ Dr. SOWMYA PRASAD
662, 11TH MAIN ROAD,
JAYANAGAR 4TH BLOCK,
BANGALORE 560011
Ph no. 9980199685
2 / NAME OF THE INSTITUTION / BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE
3 / COURSE OF STUDY & SUBJECT / M.D. IN PATHOLOGY
4 / DATE OF ADMISSION TO COURSE / 01 SEPTEMBER 2013
5 / TITLE OF THE TOPIC / A COMPARATIVE STUDY OF CONVENTIONAL PAP SMEAR AND MANUAL LIQUID BASED CYTOLOGY FOR CERVICAL CANCER SCREENING
6 BRIEF RESUME OF THE INTENDED WORK:
6.1) NEED FOR STUDY:
Cervical cancer is the leading cancer in Indian women1.
Thus, screening for cervical cancer is highly beneficial because it enables detection at the pre-invasive carcinoma stage. Thereby appropriate medical and surgical interventions can be done.
India has an approximate population of 365.71 million women over the age of 15 years who are at a risk of developing cervical cancer. Approximately 132,000 new cases are diagnosed and 74,000 deaths occur annually in India due to cervical cancer. It accounts for nearly 1/3 rd of the global cervical cancer deaths. Indian women face a 2.5 % cumulative life-time risk and 1.4 % cumulative death risk from cervical cancer1
Increased understanding of the pathogenesis of cervical cancer has enabled us to formulate effective screening methods as a part of secondary prevention.
Further reduction in the cervical cancer deaths can be achieved by :
· Better implementation of screening which has reduced the incidence and mortality of cervical cancer in the West2 as compared to India.
· There is a need to improve the diagnostic tools for cervical cancer screening in modern India. Due to visualization of the cells in a single layer, liquid based-cytology allows for improved assessment of cervical pathology.
6.2) REVIEW OF LITERATURE :
Conventional Pap smear, introduced by George Papanicolaou, has been the backbone of diagnostic cervical cytology from the past 50 years4. However, the diagnostic utility of conventional Pap smear is limited by the reduced sensitivity of detection of pre-cancerous lesions in the presence of blood, inflammation or thick areas of overlapping epithelial cells4. Fixation is variable and partial drying artefacts are common, leading to poor staining and loss of microscopic details.
Liquid-based cytology is an upcoming diagnostic procedure that is gaining acceptance globally as a superior screening method for cervical cancer. The LBC method involves rinsing all the material collected on the sampling device into a preservative fluid, creating a cell suspension. This is sent to the laboratory instead of a pre-smeared glass slide with cellular material. All cells collected from the cervix remain well-preserved. Appropriate processing can be done to remove excess blood and inflammatory exudates.
However the need for sophisticated instruments ( Sure Path, Mono Prep) may limit its implementation in a developing nation like India. India does have a number of automated LBC machines, however it doesn’t suffice for the large-scale screening we need in a populous nation like ours. Hence, a modification: Manual liquid-based cytology5,6.
In Manual Liquid-based Cytology the cells are spread out in a single layer which improves the rate of detection of the precursor lesions. It increases the detection of neoplastic lesions and reduces the over-diagnosis of benign disease processes7,8.
There are many advantages in the Manual LBC technique: it reduces the intra and inter-observer variability. Additional slides can be prepared from the collected sample. Tests for HPV markers can be done on the samples. A diagnosis can be reached by screening just a small area of the slide prepared by LBC. It also facilitates telepathology, which is an upcoming area in modern day pathology.
NM Nandini et al conducted a study in 2012 in which the cervical samples of 100 patients were examined using both conventional Pap smear and manual liquid-based cytology. It was conclusively proven that manual LBC had better sensitivity(75% vs 50%) and same specificity(89%).7
6.3) OBJECTIVES OF STUDY:
· To compare the diagnostic utility of conventional pap smear and manual liquid-based cytology( cellular and nuclear parameters) / automated method (if available)
· To compare the diagnostic validity of the two methods by subsequent histological examination of the cervical biopsy
7 ) MATERIALS AND METHODS:
7.1 : SOURCE OF DATA :
A total of 500 cervical samples will be collected for this prospective study from patients attending the gynecology out-patient department in Victoria Hospital and Bowring and Lady Curzon Hospital, Bangalore from October 2013 to May 2015.
Women presenting with white discharge PV, irregular bleeding or post-coital bleeding will be included in the study.
7.2: METHODS OF COLLECTION OF DATA:
A) STUDY DESIGN:
Prospective study.
B) STUDY PERIOD:
October 2013 to May 2015
C) PLACE OF STUDY:
Department of Pathology, Victoria Hospital and Bowring and Lady Curzon Hospital, Bangalore.
D) SAMPLE SIZE:
500 cervical samples for conventional Pap and manual LBC technique.
100 cervical biopsy samples will be studied for histopathological correlation as a gold standard.
E) INCLUSION CRITERIA:
1) Only those cervical samples which are received from the Department of Obstetrics and Gynecology, Victoria Hospital, Bowring and Lady Curzon Hospital, Bangalore and also those which are referred to the Department of Pathology, Victoria Hospital, Bowring and Lady Curzon Hospital, Bangalore are included in the study.
2) Women presenting with white discharge per vaginum, post coital bleeding or irregular bleeding will be included in this study.
F) EXCLUSION CRITERIA:
1) Women who have undergone hysterectomy.
2) Women less than 15 years
3) Women who have under gone chemotherapy and/or radiotherapy
4) Women who do not consent to be a part of the study
G) METHODOLOGY :
CONVENTIONAL PAP SMEAR: The cervical smear will be collected using an Ayre’s spatula and immediately fixed in an ether-alcohol fixative. After fixation, the smears will be stained using the conventional pap stain.
MANUAL LIQUID-BASED CYTOLOGY:
The procedure will be according to the protocol established by NM Nandini et al7.
Both the smears will be screened and the Bethesda System (2001)9 will be used to report cervical cytology.
Histological correlation will be done by taking a cervical biopsy.
H) STATISTICAL ANALYSIS:
Using “Epi-info” software, “chi square” test and “Student t test” will be used to assess accurately.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN OR ANIMALS? IF SO DESCRIBE BRIEFLY.
Yes, cervical smear and cervical biopsy will be taken.
7.4 HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION?
Has been obtained.
8 LIST OF REFFERENCES:
1. WHO/ ICO Information Centre on HPV & Cervical Cancer, 2010(Internet) 2012(cited in 2012).
Available from http://www.who.org
2. Peter A. Smith and Winifred Gray. Cervical intraepithelial neoplasia and squamous cell carcinoma of the cervix. In: Winifred Gray, editor. Diagnostic Cytopathology, 3rd Edition, London, Elsevier,2010,p723-57
3. Edmund S. Cibas. Cervical and vaginal cytology. In: Cibas and Ducatman, editors. Cytology: Diagnostic Principles and Clinical Correlates, 3rd edition, Philadelphia, Saunders Elsevier,2009,p2-10
4. Papanicolaou GN. Introduction of Pap smear in early detection of cervical malignancies. Am J Clin Path 1940; 19: 301-8.
5. Sherwani et al. Conventional Pap smear and Liquid Based Cytology for Cervical Cancer Screening- A comparative Study, Journal of Cytology 2007; 24(4):167-172
6. Kavatkar et al. Indian Journal of Pathology and Microbiology-51(2), April-June 2008
7. NM Nandini et al. Manual Liquid Based Cytology in Primary Screening for Cervical Cancer- a Cost Effective Preposition for Scarce Resource Settings, Asian Pacific Journal of Cancer Prevention, Volume 13, 2012
8. Popescu et al. Preliminary study concerning the Cytoscreen system importance (Liquid Based Cytology) in gynecological cytology, Romanian Journal of Morphology and Embryology 2005, 46(1): 23-27
9. Ritu Nayar, David C. Wilbur and Diane Solomon. The Bethesda system for reporting cervical cytology. In: Marluce Bibbo, David C. Wilbur, editors. Comprehensive Cytopathology, 3rd edition, Philadelphia,Saunders Elsevier, p79-88
9) SIGNATURE OF THE CANDIDATE:
(Dr. SOWMYA PRASAD)
10) REMARKS OF THE GUIDE:
11) NAME AND DESIGNATION OF
11.1 GUIDE : Dr. SIDDIQ M. AHMED, MD, DNB(PATH)
Professor,
Department of Pathology,
Bangalore Medical College & Research Institute,
Bangalore.
11.2 SIGNATURE:
11.3 CO-GUIDE: Dr.SURESH S. KANAKANNAVAR, MD
Associate Professor
Department of Obstetrics and Gynecology,
Bangalore Medical College & Research Institute
Bangalore
11.4 SIGNATURE:
11.5 HEAD OF THE DEPARTMENT:
Dr.A.R.RAGHUPATHI, M.D
Professor and H.O.D,
Department of Pathology,
BangaloreMedical College & Research Institute
Bangalore.
11.6 SIGNATURE:
12) 12.1) REMARKS OF THE CHAIRMAN AND PRINCIPAL:
12.2) SIGNATURE: