Download 6.1. need for the study - Rajiv Gandhi University of Health Sciences

RAJIV GANDHI UNIVERSITY OF HEALTH
SCIENCES, BANGALORE, KARNATAKA.
ANNEXURE - II
PROFORMA FOR THE REGISTRATION
OF
SUBJECT FOR DISSERTATION
By
DR G. SUGANYA
1 ST YEAR MDS
DEPARTMENT OF ORAL AND MAXILLOFACIAL
PATHOLOGY AND MICROBIOLOGY
2011
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1.
NAME OF THE CANDIDATE
AND ADDRESS:
DR. G. SUGANYA
POST GRADUATE STUDENT
DEPT. OF ORAL AND
MAXILLOFACIALPATHOLOGY AND
MICROBIOLOGY,
KRISHNADEVARAYA COLLEGE OF
DENTAL SCIENCES,
KRISHNADEVARAYANAGAR,
HUNASAMARANAHALLI,
VIA YELAHANKA, BANGALORE 562157
2.
NAME OF THE INSTITUTION:
KRISNADEVARAYA COLLEGE OF
DENTAL SCIENCES AND HOSPITAL,
KRISHNADEVARAYANAGAR,
HUNASAMARANAHALLI, VIA
YELAHANKA, BANGALORE 562157
3.
COURSE OF THE STUDY AND MASTER OF DENTAL SURGERY IN ORAL
SUBJECT:
AND MAXILLOFACIAL PATHOLOGY AND
MICROBIOLOGY.
4.
DATE OF ADMISSION TO COURSE
5.
TITLE OF THE TOPIC
1-JUNE -2011.
“SURVIVIN EXPRESSION IN THE MALIGNANT TRANSFORMATION OF ORAL
LICHEN PLANUS”.
BRIEF RESUME OF INTENDED WORK
6.1. NEED FOR THE STUDY: Oral lichen planus (OLP) is a T cell mediated autoimmune disease that leads to the
destruction of basal cell layer of oral mucosa. Clinically OLP may present in the mouth in
Reticular, Erosive, Papular, Plaque-like, Atrophic or Bullous form1. Malignant transformation
rate of erosive form of OLP was found in the range of 0.4-2.5%. Therefore identifying a
potential predictor of malignant transformation from OLP will be favorable in early
diagnosis,early treatment and prevention.
Apoptosis plays a major role in the maintainence of tissue homeostasis. The dysregulation
of apoptosis may result in malignant transformation. This evasion of apoptosis is the result of
dysregulation of inhibitors of apoptosis proteins (IAPs). Survivin is one of the IAP which is
expressed in most of the tumors and its expression is widely involved in apoptosis, proliferation
as well as in tumor metastasis2.
In studies of OSCC the expression of survivin protein has been noted to play a vital role in
oral carcinogenesis2. The use of survivin to study the pathogenesis of OLP is an increasingly
recognized diagnostic tool1.
The purpose of study is to examine the expression of survivin protein in histopathologically
diagnosed OLP cases and its variants.
6.2. REVIEW OF LITERATURE:Oral Lichen Planus is a chronic inflammatory disease that affects the skin and mucous
membrane3. The reported prevalence rate of OLP varies from 0.5-2.2% of population. The
typical age of presentation is between 30-60yrs and disease is more frequently seen in woman4.
It is a T cell mediated auto immune disease in which cytotoxic CD8 T cells trigger apoptosis of
the basal cells of oral epithelium and subsequent keratinocyte apoptosis3. The progressions of
OLP to OSCC ranges from 0.4-6.5% have been reported.
Apoptosis may aid in development of cancer research and establishing new cancer
strategies. Apoptosis or programmed cell death is a genetically controlled process which
maintains developmental morphogenesis and homeostasis of differentiated organisms by
removing senescent, unneeded/ dangerous cells. Aberration of this process leading to reduced
cell death is thought to participate in cancer by promoting increased resistance to therapy and
favouring the insurgence of transforming mutations5.
Second gene family was recently identified as regulators of apoptosis5. Survivin which
belongs to second gene family of an inhibitor of apoptotic proteins has been found to be
overexpressed in many cancers but not in normal differentiated adult tissues6. The expression of
survivin is widely involved in apoptosis, proliferation, embryo development, blood vessel
growth, immune regulation as well as tumor metastasis.
Recent evidence has shown that survivin is a predictive and prognostic parameter of poor
outcome in human cancers and as a target in detection of malignant transformation1.
6.3. AIMS AND OBJECTIVES OF THE STUDY:To compare the survivin expression in Lichen Planus and its different forms and variations in
oral mucosa and normal epithelium.
7.
MATERIAL & METHODS:
7.1. SOURCE OF DATA:7.2. METHOD OF COLLECTION OF DATA:The study will be conducted on the archival tissues of patients diagnosed
histopathologically as oral lichen planus and its variants from the Department of Oral &
Maxillofacial Pathology, Krishnadevaraya College of Dental Sciences and Hospital.
Selection of cases:
The study group will be divided into
1. Group I/Control group:- 10 cases showing stretches of normal mucosa histologically.
2. Group II:- 50 cases of histopathologically diagnosed oral lichen planus and its variants.
Inclusion Criteria:
Paraffin embedded archival tissues of patients diagnosed histopathologically as oral lichen
planus and its variants.
Exclusion Criteria:
•
Individuals with other known local and systemic disorders.
•
Metastatic lesions to the jaw.
•
Medically compromised patients.
•
Patients with anemia and blood dyscrasias
Method:
Immunohistochemical staining will be performed on 4 micrometer serial sections of formalin
fixed paraffin embedded specimens in which antibody will be directed against survivin . For
evaluating survivin expression,a scoring method will be used. A mean percentage of positive
tumor cells will be determined in a standardised area.
The intensity of survivin will be scored as follows:
0) Negative,1) Weak,+;
2) Moderate ,++;
3) Intense,+++.
Statistical analysis:
Statistical analysis will be made by “x2” analysis and “Fischer” exact test.
7.3. DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO
BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR OTHER ANIMALS?
No, Samples will be obtained from the archival embedded tissues in the Department Of Oral
and Maxillofacial Pathology, Krishnadevaraya College Of Dental Sciences, Bangalore
7.4. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN
CASE OF 7.3?
No, Ethical Clearance is not needed as we will use archival tissue from Department of Oral &
Maxillofacial Pathology, Krishnadevaraya College of Dental Sciences and Hospital for our
study.
8.
LIST OF REFERNCES:1. Oluwadayo O et al. LCK, Survivin and P-31 in the molecular biomarker profiling of oral
lichen planus and oral squamous cell carcinoma. Bioinformation 2009; 4(6):249-257.
2. Zhou S et al. Survivin as a potential early marker in the carcinogenesis of oral
submucous fibrosis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2010; 109:575581.
3. Lavanya N, Jayanthi P, Umadevi K Rao, Ranganathan K. Oral Lichen Planus : An
update on pathogenesis and treatment. Journal Of Oral and Maxillofacial Pathology
2011;15(2 ); 127-132
4. Vander waal I. Oral Lichen Planus and Oral Lichenoid lesions, a critical appraisal with
emphasis on the diagnostic aspects. Med Oral Patol Cir Bucal. 2009;14(7): E310-4
5. Muzio LL et al. Survivin expression in oral squamous cell carcinoma. British Journal of
Cancer 2003; 89: 2244-2248.
6. Megliorino R et al. Autoimmune response to antiapoptotic protein survivin and its
association with antibodies to P53 and C- myc in cancer detection. Cancer Detection and
Prevention 2005; 29: 241- 248.
9.
SIGNATURE OF THE CANDIDATE:
10.
REMARKS OF THE GUIDE:
11.
NAME AND DESIGNATION OF
11.1 GUIDE
DR.RADHIKA M B
PROFESSOR AND H.O.D.
DEPARTMENT OF ORAL AND
MAXILLOFACIAL PATHOLOGY AND
MICROBIOLOGY,
KRISHNADEVARAYA COLLEGE OF
DENTAL SCIENCES AND HOSPITAL,
BANGALORE -562157
11.2. SIGNATURE:
11.3. CO-GUIDE:
DR. LALITA.J. THAMBIAH
ASSOCIATE PROFESSOR
DEPARTMENT OF ORAL AND
MAXILLOFACIAL PATHOLOGY AND
MICROBIOLOGY,
KRISHNADEVARAYA COLLEGE OF
DENTAL SCIENCES AND HOSPITAL,
BANGALORE-562157
11.4. SIGNATURE:
11.5. HEAD OF THE DEPARTMENT DR.RADHIKA M B
PROFESSOR AND H.O.D.
DEPARTMENT OF ORAL AND
MAXILLOFACIAL PATHOLOGY AND
MICROBIOLOGY,
KRISHNADEVARAYA COLLEGE OF
DENTAL SCIENCES AND HOSPITAL,
BANGALORE -562157
11.6 SIGNATURE:
12.1 REMARKS OF THE
PRINCIPAL:
12.2 SIGNATURE OF THE
PRINCIPAL:
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL
HUNASAMARANAHALLI, BANGALORE-562157
ETHICAL CLEARANCE FOR DISSERTATION STUDY
Ethical clearance for dissertation study “SURVIVIN EXPRESSION IN THE
MALIGNANT TRANSFORMATION OF ORAL LICHEN PLANUS” by
DR.G. SUGANYA, postgraduate student in the Department of Oral and Maxillofacial
Pathology, under the guidance of Dr. Radhika M. Bavle Prof & Head, Department of Oral
and Maxillofacial Pathology, Krishnadevaraya College of Dental Sciences and Hospital,
under Rajiv Gandhi University of Health Sciences, Karnataka.
Ethical committee meeting was held on 4th November, 2011 in the Boardroom of
Krishnadevaraya College of Dental Sciences & Hospital.
The Members discussed all the ethical issues involved
1. Review of literature and remarks of previous studies.
2. Risks and expected beneficial effects.
3. Cost factor.
4. Supervision by Senior Staff members.
5. ICMR guidelines for Research Studies.
6. The members were satisfied regarding all the above Ethical issues concerned and
ethical clearance was granted for the Dissertation Study.
ETHICAL COMMITTEE MEMBER
SN
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NAME AND DESIGNATION
POSITION
Dr. H. Nandakumar, Principal & HOD Dept.of
Oral and maxillofacial Surgery
Dr. Sharathchandra, Prof & HOD, Dept of
Conservative Dentistry
Mr. Mohumed Sadiq.B.A, Advocate
Mr. Gundu Rao, NGO, Social Activist
Dr. Jai Prakash Alva, Medical Supdt, KHRC
Dr. Nikhilananda Hegde, HOD, Orthodontics
Dr. Prabhuji MLV, HOD Dept of Periodontics
Dr. Shiva Shankar, Prof. & HOD,
Prosthodontics
Dr. M.B.Radhika, Prof.& HOD, Oral
Pathology
Dr. Srinath, Professor, Oral Surgery
Dr. Rame Gowda, Physician, KHRC
Dr. H.S.Prabhakar, Anaesthetist, KHRC
Chairman
Co- Chairman
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
SIGNATURE