THESIS SYNOPSIS

DR. SHERASHIYA PINHAJ A.

DEPARTMENT OF ORAL PATHOLOGY AND MICROBIOLOGY

SHRI RAJIV GANDHI DENTAL COLLEGE AND HOSPITAL,CHOLANAGAR, HEBBAL,

BANGLORE-32

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

4th BLOCK, JAYANAGAR,BANGALORE,KARNATAKA

ANNEXUREII

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / DR.SHERASHIYA PINHAJ A.
POST GRADUATE STUDENT,
DEPT OF ORAL PATHOLOGY AND MICROBIOLOGY,
SHRI RAJIV GANDHI DENTAL COLLEGE AND HOSPITAL, CHOLANAGAR, HEBBAL,
BANGLORE-32
2. / NAME OF THE INSTITUTION / SHRI RAJIV GANDHI DENTAL COLLEGE AND HOSPITAL, CHOLANAGAR, HEBBAL,
BANGLORE-32
3. / COURSE OF THE STUDY AND SUBJECT / MASTER OF DENTAL SURGERY
DEPARTMENT OF ORAL PATHOLOGY AND MICROBIOLOGY.
4. / DATE OF ADMISSION TO COURSE / AUGUST 31ST– 2013
5. / TITLE OF THE TOPIC: “EFFECTIVENESS BETWEEN MODIFIED LIQUID-BASE CYTOLOGY WITH CONVENTIONAL EXFOLIATIVE CYTOLOGYBY GIEMSA AND PAPANICOLAOU STAIN IN ORAL CANCER”
6. / BRIEF RESUME OF THE INTENDED STUDY:
6.1) Need for the study:
Oral cancer is the most common cancer and constitutes a major health problem in developing countries,representing the leading cause of death. Detection of oral cancer in the early asymptomatic stage dramatically improves cure rates and patients quality of life.[1]
Exfoliative cytology in the oral cavity has been use for early detection but proved to be a little value because of inadequate sampling of the cells,staining and cellular detail.[1,2]
Modifiedliquid based cytology (LBC) has advantages over conventional cytology by producing homogenous smears which increases specificity and sensitivity and can be an effective and non invasive means of detecting dysplasia as well as early carcinoma.[1,3,4,5,6]
The value of oral brush biopsy with computer assisted analysis has been well documented in Western Studies. This requires specially designed oral brush, sophisticated laboratory assistance with computer application and it is highly expensive.[6]
So the present study has been planned to evaluate the efficiency comparison of Modifiedliquid based cytology with conventional cytology by distribution of cells, staining quality(using PAP and Giemsa stain), clear back ground and cellular detail.
6.2 Review of literature:
A comparison quantitative survey study conducted between liquid-based cervical cytology(Thin prep) with conventionally prepared Papanicolaou smears of Forty-seven English-language articles published between January 1990 and September 2002 were identified through Medand manual searches at Department of Obstetrics and Gynecology, State University of New York at Brooklyn ,USA ,comparing liquid-based cervical cytology with conventional cytology for 35,172 patients; and 10 articles compared cytology with histology or other standard diagnoses for 21,752 patients. Three of these articles contained both types of comparisons. The standard cytology classification into negative, atypical, low-grade (LGSIL) and high-grade (HGSIL) squamous intraepithelial lesions, and carcinoma was applied. The two methods tend to agree in 89 and 92% of cases based on the five-level and dichotomous classifications, respectively, liquid-based cervical cytology(Thin prep) was reported as normal in 93.5% of cases of normal conventional smears. The remaining 6.5% of ThinPrep slides were classified as follows: atypical, 4.55%; LGSIL, 1.56%; HGSIL, 0.36%; invasive cancer, 0.007%. Sensitivity rates, relative to histology, were 6 (conventional) and 76% (ThinPrep), and specificity rates were 79% (conventional) and 86% (ThinPrep). They conclude that liquid-based cervical cytology(Thin prep) to be more sensitive and specific than conventional smears in detecting cervical dysplasia.[3]
An another Review article of Application of cytology and molecular biology in diagnosing premalignant or malignant oral lesions has shown that liquid-based preparations resulted in higher specimen resolution as well as presenting a better cytological morphology for pemphigus vulgaris, SQUAMOUS CELL CARCINOMAS, viral lesions and fungus infections.[1]
An another study was conducted in 100 patients with suspicious oral lesions at department of histopathology and cytology, faculty of medicine laboratory sciences ,Khartoum, Sudan, to compare the utility of centrifugated LBC preparation with that of direct preparation in oral lesions, by Papanicolaou (Pap) and May Grünwald-Giemsa's (MGG) methods., staining quality with the Pap method,39% and 69% were excellent staining quality,25% and 20% were good, and 36% and 11%were acceptable for CLBC and direct preparation, respectively. In MGG method, 9% and22% were excellent staining quality, 23% and36% were good and 68% and 43% were acceptable for CLBC and direct preparation respectively. They conclude that comparing the staining quality between the LBC and direct smears ,CLBC preparation shown superior staining quality and clear cellular detail compared to that of direct preparation.[4]
An another study was conducted in 25 patients with suspicious 26 oral lesions at Mashhad faculty of dentistry and otorhinolaryngology Departments of OMID hospital ,Mashhad, Iran to evaluate of the diagnostic value of a Modified liquid-based cytology using Oralcdx brush in early detection of oral potentially malignant lesions and oral cancer with scalpel biopsy simultaneously from the same area. According results; sensitivity, specificity, positive and negative predictive values of modified LBC technique were calculated respectively 88.8%,100%100%and 80%.Positive likelihood ratio (LR+)and Negative likelihood ratio (LR-)were infinity and 0.11 respectively (no false positive results).they conclude that Modified liquid-based cytology is a useful tool for screening of oral premalignant and malignant lesions.[6]
An another case control study was conducted in 182 (case) with suspicious oral squmous cell carcinoma (OSCC) and 179 (control) normal buccal mucosa at the Head and Neck ambulatory service of Hospital do Cancer de Pernambuco,Brazil, to evaluate the sensitivity, specificity, and concordance between conventional cytology and liquid-based cytology. Among the cases, the cytologic methods demontrated a sensitivity= 96.9% (IC= 95%: 92.5% to 98.8%), specificity= 75.0% (IC=95%: 21.9% to 98.7%), and accuracy= 96.3% (IC=95%: 92.5% to 98.5%). Among the controls the results were: sensitivity= 91.0% (IC=95%: 84.1% to 95.2%);, specificity= 57.5% (IC=95%: 41.0% to 72.6%), and accuracy= 82.7% (IC=95%: 76.3% to 88.0%).They conclude that conventional cytology and liquid-based cytology demonstrated a diagnostic concordance with histopathology of more than 90%.. When compared to each other, conventional cytology and liquid-based cytology showed liquid-based cytology a high sensitivity and reasonable specificity how ever conventional cytology only show specificity . [5]
An another study was conducted in 50 patients with oral lesions comprising of normal mucosa (n=14), hyperkeratotic lesions (n=17), ulcerated lesions ( n=7) and atrophic lesions ( n=12) were selected at Department of Oral Pathology and Microbiology, Saraswati Dental College and HospitalLucknow, Uttar Pradesh, India. To compare the utility of centrifuged liquid based cytology with conventional cytology in oral lesions after staining with Papanicolaou (PAP) stain. The stained smears were compared for seven morphological parameters such as adequacy of smear, clear background, cell distribution, smear thickness, cell morphology, and presence of blood, inflammatory cells, microbial colonies and artifacts. RESULT : There was a statistically significant difference ( P<0.001) between centrifuged liquid based cytology and conventional cytology when clear background was evaluated while in all other parameters the difference was not significant.Based upon this they given conclusion that Centrifuged Liquid based cytology showed clearer background than conventional brush cytology in oral lesions.[2]
6.3 Aims and Objectives of Study:
  • To evaluate the sensitivity and specificity of modified liquid based cytology to analysis in the detection of malignant lesions.
  • To compare the efficiency of modified liquid based cytology with conventional cytology in oral cancer.

7. / MATERIALS AND METHODS
7.1 Source of the data
Patients attending the department of oral medicine and radiology/oral pathology Shri Rajiv Gandhi Dental College and hospital Bangalore and other cancer institute around Bangalore city will be included in the study group after obtaining an informed consent from the patients with clinically diagnosed oral squamous cell carcinoma.
Inclusion criteria
1. Any clinically suspect malignant lesion.
2.Histo pathologically diagnosed oral squamous cell carcinoma.
Exclusion criteria
1. Proliferative, traumatic, or immune-mediated epithelial lesions (e.g., papilloma, aphthous ulcer, lichen planus, traumatic ulcer, etc.)
7.2 METHOD OF COLLECTION OF DATA
A minimum of 50 patients with clinically diagnosed as oral squamous cell carcinoma.
Clinical examination and study parameters.
A structured proforma will be used to collect relevant information from each patient regarding the adverse habits and detailed clinical examination of the lesion will be done.
A complete transepithelial biopsy will be obtained using commercially available cytodiagnostic brush using moderate pressure. The brush is repeatedly brushed in one direction over the lesion until pin-point bleeding is seen which ensures sample of all epithelial layers including basal layer and superficial layer. The material from the brush will be spread on the middle third of 3 clean dried glass slides and fixed immediately using 95% ethyl alcohol for staning with giemsa and the papanicolaou’s stain.[2,4]
For modified liquid based cytology after taking the brush biopsy, the brush will be dipped into a test tube containing 20ml of 95%ethanol+6 ml of glacial acetic acid+74 ml normal saline(Merck Darmstat ,Germany)centrifuged with 3000 rpm for 10 minand than 100 mm3 sediment again centrifuged with 1000 rpm for 5 minusing vortex or cytospin. The formed supernatant was poured off and replaced by acid alcohol for 30 min. Then thesupernatant was discarded leaving only a fewdrops which were shook vigorously with acid alcohol. Thereafter, a drop of coating medium (glycerin/albumin) was added. Then three smears (wet fixed and air dried) were made from each specimen on moist, clean glass slides and stain with giemsa and the papanicolaou’s stain.[2,4,6]
.
Evaluation
All the slides will be examined manually using light binocular microscope under 10X magnification to evaluate distribution of cells, staining quality, clear back ground and cellular detail(nucleus morphology, nucleus cytoplasmic ratio and overall cell morphology) between Modifiedliquid based cytology with conventional cytology .
Statistical analysis;
Statistical data obtained which include all the para meters will be subjected to chi - square test.
7.3 Does the study require any investigations (or) interventions to be conducted in patients (or) other humans (or) animals?
Yes
7.4 Has ethical clearance been obtained from your institution?
Yes
8. / LIST OF REFERENCES;
  1. Mehrotra R,Gupta A,Singh M and Ibrahim R:ReviewApplication of cytology and molecular biology in diagnosing premalignant or malignant oral lesions.Molecular Cancer2006,5:11 1-9.
  2. Dwivedi N,Agarwal A,Raj V,Kashyap B,Chandra S: Comparison of centrifuged liquid based cytology method with conventional brush cytology in oral lesions.Eur J Gen Dent 2012,1:392-96.
  3. Ovadia A, John P, David S:Performance of ThinPrep liquid-based cervical cytology in comparison with conventionally prepared Papanicolaou smears:a quantitative survey.Gynecologic Oncology 2003,90:1 137–144.
  4. Ahmed H,Edris A, Mohmed E, .Hussein M:Value of centrifugated liquid-based cytology by Papanicolaou and May-Grünwald in oral epithelial cells.Rare Tumors 2009,1:12 31-33.
  5. De lacerda vidal A, Caldas junior A, De mello R, Brandao V, Lima P, Figueiroa J:Conventional Cytology versus liquid-based cytology for prevention and early diagnosis of oral squamous cell carcioma (OSCC).OdontolClín-Cient Recife2011,10:1 31-36.
  6. Delavarian Z,Motasham N, Mozaffari P, Pakfetrat A, Shakeri T, Maddah R:Evaluation of the diagnostic value of a Modified Liquid-Based Cytology using OralCDx ® Brush in early detection of oral potentially malignant lesions and oral cancer.Med Oral Patol Oral Cir Bucal 2010,15:5 71-76.

9. / SIGNATURE OF THE CANDIDATE
10. /

REMARKS OF THE GUIDE

11. / NAME & DESIGNATION OF (In block letters)
11.1Guide / DR.YOGESH.T L
READER,
DEPARTMENT OF ORAL PATHOLOGY & MICROBIOLOGY
SHRI RAJIV GANDHI DENTAL COLLEGE AND HOSPITAL, CHOLANAGAR, HEBBAL,
BANGLORE-32
11.2 Signature of guide
11.3 Co-Guide ( if any )
11.4 Signature
11.5 Head of the Department / PROF.(DR.)REKHA PATIL.
HEAD OF THE DEPARTMENT
DEPARTMENT OF ORAL PATHOLOGY & MICROBIOLOGY,
SHRI RAJIV GANDHI DENTAL COLLEGE AND HOSPITAL, CHOLANAGAR, HEBBAL,
BANGLORE-32
11.6 Signature
12 / 12.1 Remarks of the
Chairman and
ThePrincipal
12.2 Signature / PROF. (DR.) VAIBHAVI JOSHIPURA.