RAJIVGANDHIUNIVERSITYOF HEALTH SCIENCES , KARNATAKA

Bangalore-5600041

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of the Candidate
and address (in block letters) / Dr. SAVITHADEVI S.M
W/O Dr. G.B. JYOTHI PRAKASH
#2334 , 9THMAIN , MCC A BLOCK , DAVANGERE -577004
2. / Name of the Institution / J.J.M.MEDICALCOLLEGE
DAVANGERE -570004
KARNATAKA
3. / Course of the Study & Subject / POST GRADUATE
M D IN PATHOLOGY
4. / Date of Admission to Course / 13/10/2011
5. / Title of the topic / CYTOLOGY OF UTERINE CERVIX –A CORRELATION STUDY WITH COLPOSCOPY AND HISTOPATHOLOGY.
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the Study:
Cytologic samples used in colposcopic evaluation are obtained by use of the Pap smear. Pap smear is widely used for screening the lesions in the cervix.1
Biopsy to confirm the presence of cervical carcinoma has long been used , but the more recent use of colposcopically directed biopsy on patients with abnormal Pap smear has allowed the recognition and treatment of cervical disease at a much earlier stage . The effectiveness of the diagnostic combination of colposcopy , cytology and histopathology in reducing cervical cancer is evidenced by the marked decrease in the death rate from cervical cancer during the last three decades. 1
Using colposcopic and cytologic techniques for early detection of cervical neoplasia is one of the most challenging and rewarding areas in gynaecological malignancy because this type of disease is curable when diagnosed and treated in the early stages , As there is a potential for effective prevention of cervical cancer by screening , there is a need for a correlation study of cytology , colposcopy, histopathology. 1
6.2 Review of Literature
considered as possible agents involved in the genesis of cancer of the uterine ce Carcinoma of uterine cervix and its precursors belong to the best studied forms of human cancer. It has been repeatedly documented that invasive carcinoma of the uterine cervix , regardless of type , develops from precursor lesions or abnormal surface epithelium. During the last 30 years of the 20thcentury , several sexually transmitted viruses were rvix . The two most important agents are herpesvirus type 2 and human papillomovirus(HPV).2
Proper identification of the aetiologic agent for leucorrhoea will assure that appropriate therapy is initiated . This may be done by Pap smear. Many women screened by colposcopy have atypical changes evident on both colposcopy and cytology .Therefore it is recommended that “All sexually active women continue to undergo pelvic examination and routine cytologic screening on a yearly basis.1
The term dysplasia was suggested by a pathologist William Ober to Papanicolaou. The Diagnostic System Dysplasia -Carcinoma In Situ was formalised in 1962 as “An International Agreement On Histological Terminology For The Lesions Of The Uterine Cervix.2 Richart (1967) who followed , by cytology and colpomicroscopy a group of 557 women with varying degrees of dysplasia for an average period of 36 months, concluded that all these lesions constitute spetrum of abnormalities for which the terms cervical intraepithelial neoplasia (CIN) was suggested .2
With the passage of time , it became apparent that the histologic and cytologic nomenclature should be simlar, if not identical. To facilitate the exchange of information among investigators and laboratories, in December 1988 , a committee of experts, convened under the auspices of the National Cancer Institute (United States) in Bethesda , Maryland , proposed a system of diagnostic guidelines for the interpretation of the cervicovaginal smears . The Bethesda system (Modified in 2001) was officially accepted by the federal authorities in the United States . The cytological features of the precursor lesions of squamous carcinomas of the uterine cervix were divided into two groups :- Low grade squamous intraepithelial lesions (LGSIL) and High grade squamous intraepithelial lesions.(HGSIL). 2,3 European panel recommended that the modified Bethesda system , the new classification should be adopted by the UK National Health Service for Cervical Screening Programme. 4 Sonia prandi et al (2006) have successfully proved Applicability of the Bethesda system 2001 to a public Health system.5 Split –Sample clinical trials for liquid based Papanicolaou (Pap) smears demonstrated that the liquid based Pap smear was a safe and effective replacement for the conventional Pap smear. Maurice Fremont-Smith et al (2004) found that Surepath Pap smear to outperform the conventional slides in the detection of HSIL+ & LSIL+ cytologic lesions of the cervix and reduced the number of unsatisfactory diagnosis. 6A.ullal et al studied the role of cervical cytology and colposcopy in detecting cervical glandular neoplasia. Endocervical glandular neoplasia detected on cytology in their study was predictive of significant cervical pathology even when colposcopy was normal . 7
In 2008 European guidelines for quality assurance in cervical cancer screening were finalised . The guidelines cite statements as simple as –“ the cervical epithelium needs time to regenerate after cytology . Repeat cytology should not be performed within three months after a previous Pap smear.”.8
Patrick Petignat et al (2004) assessed the age specific prevalence of High risk-HPV infection and the correlation between High risk –HPV Status and the cytologic diagnosis. 9 Triage to colposcopy of patients with cytologic abnormalities associated with a moderate Positive predictive value for lesion s of CIN2 & above by using HPV and P16 testing may become a cost effective procedures in the future.
6.3 Objective of the study :
( i ) To study the cytological features of uterine cervix.
(ii)To correlate the cytological features with colposcopy and
histopathology findings .
7. / MATERIALS AND METHODS:
7.1Source of data
Patients referred to pathology department of J J M Medical college. Davangere for cytology and biopsy interpretation of uterine cervix during the two year period from October-2011 to September-2013.
7.2Method of collection of data (Including sampling procedure , if any )
Following sequential steps will be employed in the study
(i)Complete clinical examination
(ii) Per speculum examination for direct visualization of uterine cervix
(iii)Pap smear obtained from squamo-columnar junction of uterine cervix.
(iv)Colposcopic examination done at the discretion of consulting Gynaecologist.
a)colposcopic examination after application of aceticacid.
b)Colposcopic examination after application of Iodine.
(v)Biopsy :colposcopic guided/ nonguided punch biopsy/Total hysterectomy is done at the discretion of the gynaecologist.
Pap Smear will be immediatly fixed in 95 % ethylalcohal and subsequently stained with Papanicolaoustain . Biopsy specimens will be fixed in 10% formalin & processed to obtain paraffin sections followed by stains with H&E stains. Later cytological findings will be correlated with colposcopichistopathologicalfindings . Statistical analysis for efficacy of the cytology will be made.Results will be subjected for appropriate statistical analysis.
To test the association, chi-square test will be used for assessing diagnostic value of cytological findings with colposcopy and Histopathological finding. ( Sensitivity & Specificity)
SAMPLE SIZE : 50 CASES
INCLUSION CRITERIA
(i)Women clinically having lesions in uterine cervix
(ii)Women above the age of 30 years
EXCLUSION CRITERIA
(i)Non Co-Operative patients
(ii)Women below 30 years
(iii)Women who has undergone previous total hysterectomy
(iv)Women on treatment with Radiotherapy and Chemotherapy
7.3Does the study require any investigations or interventions to be conducted on patients or other humans or animals ?if so , please describe briefly ?
(i) Smears of uterine cervix.
(ii) Colposcopy of uterine cervix.
(iii) Biopsy of uterine cervix
7.4Has ethical clearance been obtained from your institution in case of 7.3?
Yes.
8 / LIST OF REFERENCES :
(1) Introduction toDiagnostic techniques. Giuntoli LR, Atkinson BF, Ernst SC, Rubin MM, Egan SV. Atkinson’s correlative atlas of colposcopy, cytology and Histopathology :Philadelphia : J.B. Lippincott company; 1987.p 2, 38.
(2) Squamous carcinoma of the uterine cervix and its precursors. Koss LG. Koss’Diagnostic cytology And its Histopathological Bases. 5thedition .Philadelphia : Lippincott Williams and Wilkins ; 2006. VolI .p 283,286,306-7,312.
(3) Solomon D, Davey D, Kurman R, Moriarty A, Connor OD, Prey M et al . Terminology for Reporting Results of cervical cytoloty .JAMA 2002 ; 287 (16) : 2114-2119.
(4) Kocjan G, Priolett BC, Desai M, Koutselini H, Mahovlic V, Oliveira MH et al . BSCC ,Bethesda or other ? Terminology in cervical cytology European panel discussion. Cytopathology 2005 ;16 :113-119.
(5) Sonia Prandi , BeccatiDonotella , Aloysia DG, Fulgenzi P , Gabrielli M , Ghirardini C. Applicability of the Bethesda System 2001 to a Public Health Setting . Cytopathology 2006 October 25 ; 108(5) : 271-76.
(6) Smith FM, Marino J, Griffin B, Spencer L, Bolick D. Comparison of the SurePathTM Liquid Based Papanicolaou Smear with the Conventional Papanicolaou Smear in a Multisite Direct-to-vial Study . Cytopathology 2004 October 25 ; 102(5) : 269-79.
(7) Ullal A, Roberts M, Bulmer JN, Mathers ME, Wadehra V. The role of cervical cytology and colposcopy in detecting cervical glandular neoplasia .cytopathology 2009 ; 20 : 359-366 .
(8) EU guidelines : advocating a Unified multidisciplinary approach [ editorial]. Cytopathology2008 ; 19 : 337-341.
(9) PetignatP . Age-Related Performance of Human Papillomavirus Testing used as an Adjunct to Cytology for cervical Carcinoma Screening in a Population with a Low Incidence of Cervical Carcinoma .Cytopathology 2004 June 25 :105(3) : 126-32.