RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.
ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. NAME OF THE CANDIDATE AND : Dr. NISHTHA BATRA
ADDRESS POST GRADUATE IN
DEPARTMENT OF PATHOLOGY,
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE – 570 001.
2. NAME OF THE INSTITUTION : MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE, MYSORE.
3. COURSE OF STUDY AND : M. D. PATHOLOGY.
Subject
4. DATE OF ADMISSION TO : 24.06.2011
THE COURSE
5. TITLE OF THE TOPIC : “FINE NEEDLE ASPIRATION CYTOLOGY OF HEAD AND NECK LESIONS IN HIV SERO-POSITIVE PATIENTS.”
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Acquired immune deficiency syndrome (AIDS) caused by the Human Immunodeficiency Virus, is now considered to be a major public health problem. The Immune status is abnormal in HIV infected patients. HIV not only invades T-lymphocytes of CD4 type but also infects macrophages and B-lymphocyte elements. This leads to a profound immunodeficiency that affects both cellular and humoral immunity resulting in opportunistic infections as well as benign and malignant neoplasms. Head and neck lesions are common manifestations of HIV. In India, not many studies focusing on FNAC of head and neck lesions in HIV sero-positive patients have been published. Keeping this in view, the present study of FNAC of head and neck lesions in HIV sero-positive patients is undertaken.
6.2) REVIEW OF LITERATURE:
· In 2002, Satyanarayana S. et al conducted a study in which Fine needle aspiration cytology of 196 HIV positive cases was undertaken and correlated with CD4 count. The commonest opportunistic infection noticed was tuberculosis as seen in 34.2% of patients. Cytomorpholologically, reactive pattern with acid fast bacilli (AFB) positivity was observed in 16.4% of TB cases. In a large Western study, 37% of aspirates were benign/reactive, 13% suspicious of malignancy,14% specific infections with stainable organisms, 16% inflammatory and 20% reported as inconclusive.1
· HIV confers more than a 25 fold increase in incidence of Non-Hodgkins` lymphoma as compared with the general population. Approximately, 20% of long term survivors ultimately develop lymphomas, mostly of B-cell type and primarily immunoblastic large-cell type(60%) or Burkitt`s like(20%).2
· Head and neck squamous cell carcinoma is the third most common head and neck malignancy for patients with HIV infection, after Kaposi sarcoma and non–Hodgkins lymphoma. Studying head and neck squamous cell carcinoma in HIV-positive patients is important for optimizing treatment protocols and early detection strategies for this at-risk group.3
· According to a review article on carcinomas arising in head and neck region in HIV-positive patients, the majority of malignancies arising in head and neck among patients with AIDS are Kaposi sarcoma and non–Hodgkin’s lymphoma. Patients with AIDS are also at increased risk of developing mucosal squamous cell carcinoma, nasopharyngeal carcinoma, lymphoepithelial carcinoma of salivary gland, and Merkel cell carcinoma in this anatomic region. HIV positive patients with these cancers present at a younger age , with more aggressive disease and worse prognosis.4
· It has been well documented that 70-90% of patients with HIV will at some stage present with an ENT manifestation of the disease. Parotid gland enlargement is commonly encountered in HIV-infected adults and children who are not on anti-retroviral therapy. HIV-associated cystic lympho-epithelial disease (benign lympho-epithelial cysts) is a disease process unique to HIV-infected individuals and the etiology is thought to be related to a lymphoid response to HIV infection.5
· India has a large and evolving HIV epidemic. As elsewhere, non-Hodgkin’s lymphomas dominate the profile of recognized cancers, with large cell diffuse lymphoma being the most common type. Hodgkin’s lymphoma is proportionally increased. In contrast, Kaposi sarcoma is rare. Head and neck tumour incidence may also be increased, an important concern since these tumours are among the most common in India.6
· Less commonly, patients with AIDS develop cystic and solid intra-parotid tumours which have been referred to as either cystic benign lympho-epithelial lesions (BLEL) in AIDS or AIDS related parotid cysts. Patients with HIV infection are at a risk of developing infectious sialadenitis. Potential opportunistic pathogens include CMV, PCP, adenovirus and Histoplasma capsulatum.7
· A fine needle aspiration study was done at the School of Tropical Medicine, Kolkota, between July 1997 and December 2000, in which 1616 sero-positive cases were identified by Western Blot test. 472 patients had generalized lymphadenopathy. CD4 count could be done in 54 out of these 472 cases. Reactive hyperplasia was seen in 30 cases whose CD4 count varied between 411-945 cells/µl. Evidence of tuberculous lymphadenitis was detected in 22 cases with the CD4 count varying between 113-422 cells/µl . Non-Hodgkin’s lymphoma was diagnosed in 2 cases with a CD4 count of 79-113 cells/µl. There is no doubt that, biopsy is a more reliable diagnostic tool, but FNAC can serve as an alternative method and may be practised for diagnosis of opportunistic infections in AIDS/HIV namely tuberculosis, histoplasmosis, toxoplasmosis and malignant lesions like Kaposi sarcoma and lymphoma.8
· A study of 231 cases was conducted from September 2004 to August 2005, in which all the cases presented with lymphadenopathy and proved to be HIV positive as per NACO guidelines. It was concluded that, FNAC is a valuable tool for identification of opportunistic infections, neoplastic and non-neoplastic lesions. Correlation of lesions with CD4 T- lymphocyte counts provides information about immune status and stage of disease. In addition, correlative study with AFB staining helps in assessing the status of disease activity in tuberculous lymphadenitis.9
6.3 OBJECTIVES OF THE STUDY
1. To study the cytological spectrum of head and neck lesions in HIV sero- positive cases.
2. To correlate the cytological patterns of head and neck lesions in HIV sero- positive cases with the clinical, haematological and immunological parameters.
7. MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
Fine needle aspiration to be performed on HIV sero- positive patients with head and neck lesions, referred to the Department of Pathology from K.R. Hospital attached to Mysore Medical College and Research Institute, Mysore.
Sample size: A minimum of 50 HIV positive patients with palpable head and neck swellings.
7.2 METHODS OF COLLECTION OF DATA
In the present study, fine needle aspiration will be done on the HIV sero-positive patients with head and neck lesions referred from K.R. Hospital to the Department of Pathology attached to Mysore Medical College and Research Institute. The cases include clinically palpable head and neck swellings excluding thyroid lesions. The study will be conducted for a period of 18 months.
For fine needle aspiration, a 22 to 24 gauge needle with a 10 ml syringe will be used. A direct smear will be made. The smear will be fixed with Carnoy`s fluid or 95% alcochol. For each case, Hematoxylin and Eosin stain will be done. Special stains like Ziehl-Neelson, Gomori’s methinamine silver, Papanicolaou and Giemsa shall be performed whenever required.
CD4 count will be done with the help of flow cytometer by using the facilities in the department of microbiology of Mysore Medical College and Research Institute.
A complete haemogram including Total leucocyte count, absolute lymphocyte count, platelet count and blood picture shall be done.
Clinical details and other relevant laboratory data will be obtained from the patients` medical records
Inclusion criteria:
1. All HIV sero-positive patients with palpable head and neck swellings.
Exclusion criteria:
1. HIV sero-negative patients with head and neck swellings.
2. HIV sero-positive patients with thyroid enlargement.
.
7.5 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
Yes. The study requires Fine needle aspiration on HIV sero-positive patients with head and neck lesions. Ancillary investigations shall include CD4 count and complete haemogram.
No investigations or interventions on other humans or animals are necessary.
7.6 Has ethical clearance been obtained from your institution in case of 7.5:
Yes (Copy enclosed)
7.7 Duration of study: 18 months (30thNovember 2011 to 31st May 2013 ).
8. LIST OF REFERENCES:
.
1. Satyanarayana S, Kalghati AT, Muralidhar A, Prasad RS, Jawed KZ, Trehan A. Fine needle aspiration cytology of lymph nodes in HIV infected patients.MJAFI2002;58:33-37.
2. Harrisons LB, Sessions RB, Hong WK. Head and neck cancer a multi disciplinary approach.Philadelphia:Lipincott-Raven publishers;1999.pp987-9.
3. McLemore MS, Haigentz M, Jr, Smith RV, Nuovo GJ, Alos L, Cardesa A, Genseler MB. Head and neck Squamous cell carcinomas in HIV-positive patients: A preliminary investigation of viral associations .Head Neck Pathol 2010;4(2):97-105.
4. Purgina B, Pantanowitz L, Seethala RR. A review of carcinomas arising in the head and neck region in HIV-positive patients. Pathology Research International 2011(2011),ArticleID469150,12pages. http://www.hindawi.com/journals/pri/2011/469150/.
5. Lubbe DE. HIV and ENT .CME 2004;22(5):250-253.
6. Biggar RJ, Chaturvedi AK, Bhatia K, Mbulaiteye SM. Cancer risk in persons with HIV/AIDS in India:a review and future directions for research. Infect Agents Cancer 2009,4:4 doi 10.1186/1750-9378-4-4.
7. Gnepp DR. Diagnostic surgical pathology of head and neck.1st ed.Philadelphia:W B Saunders; 2001.pp329-33.
8. Shobhana A, Guha SK, Mitra K, Dasgupta A, Neogi DK. People living with HIV infection/AIDS-A study on lymph node FNAC and CD4 count. Indian J Med Microbiol 2002;20:99-101.
9. Kumarguru ,Kulkarni MH, Kamakeri NS. FNAC of peripheral lymphnodes In HIV positive patients. Scientific Medicine 2009;1(2).
9. Signature of the Candidate :
(Dr. NISHTHA BATRA)
10. Remarks of the Guide :
11. Name and Designation of
11.1 Guide : Dr. A. L. HEMALATHA
M.D., D.C.P.
PROFESSOR AND HEAD OF
THE DEPARTMENT OF PATHOLOGY,
MYSORE MEDICAL COLLEGE
& RESEARCH INSTITUTE
MYSORE.
11.2 Signature of Guide :
11.3 Co-Guide : Dr. SHARATH KUMAR H.K.
M.D.
ASSOCIATE PROFESSOR,
DEPARTMENT OF
PATHOLOGY, MYSORE
MEDICAL COLLEGE
AND RESEARCH INSTITUTE
MYSORE
11.4 Signature of Co-guide :
11.5 Head of the Department : Dr. A.L HEMALATHA
M.D., D.C.P.
PROFESSOR AND HEAD OF
THE DEPARTMENT OF PATHOLOGY,
MYSORE MEDICAL COLLEGE
AND RESEARCH INSITUTE
MYSORE.
11.6 Signature of
Head of the Department :
12. Remarks
12.1 Remarks of the Dean :
and Director
12.2 Signature of the Dean :
and Director
ETHICAL COMMITTEE CLEARANCE
1. TITLE OF THE DISSERTATION : “FINE NEEDLE ASPIRATION CYTOLOGY OF HEAD AND NECK LESIONS IN HIV SERO-POSITIVE PATIENTS.”
2. NAME OF THE CANDIDATE : Dr. NISHTHA BATRA
3. SUBJECT : M.D. PATHOLOGY.
4. NAME OF THE GUIDE : Dr. A.L. HEMALATHA.
M.D.,D.C.P.
PROFESSSOR AND HEAD OF
THE DEPARTMENT OF
PATHOLOGY,
MYSORE MEDICAL COLLEGE
& RESEARCH INSTITUTE,
MYSORE.
5. APPROVED/NOT APPROVED :
(If not approved, suggestion)
MEDICAL SUPERINTENDENT MEDICAL SUPERINTENDENT
K.R. Hospital, Cheluvamba Hospital,
Mysore. Mysore.
PROFESSOR AND HEAD PROFESSOR AND HEAD
Department of Medicine, Department of Surgery,
K.R.Hospital, Mysore. K.R.Hospital, Mysore.
MEDICAL SUPERINTENDENT LAW EXPERT
PKTB Hospital,
Mysore.
THE DEAN AND DIRECTOR
Mysore Medical College and Research Institute,
Mysore.
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