Annexure Ii: Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
ANNEXURE II
SYNOPSIS FOR REGISTRATION OF SUBJECT FOR

DESSERTATION
1 NAME OF THE CANDIDATE Dr. JAYAKUMAR.C.K

POST GRADUATE IN
PATHOLOGY,
BANGALORE MEDICAL
COLLEGE &
RESEARCH INSTITUTE,
BANGALORE-560002
2 NAME OF THE INSTITUTION BANGALORE MEDICAL

COLLEGE & RESEARCH
INSTITUTE, BANGALORE
3 COURSE OF STUDY & M.D. IN PATHOLOGY

SUBJECT
4 DATE OF ADMISSION TO 24 MAY 2010

COURSE
5 TITLE OF THE TOPIC “STUDY OF SERUM

ADENOSINE DEAMINASE
LEVELS IN FNAC CONFIRMED
CASES OF TUBERCULOUS
LYMPHADENITIS”
6 BRIEF RESUME OF THE INTENDED WORK:

6.1) NEED FOR STUDY
In our routine practice we are coming across many cases which are reported
as reactive lymphadenitis by fine needle aspiration cytology (FNAC). These cases
come back at a later date with full blown disease of tuberculosis. Our study is
mainly concerned to diagnose early tuberculosis and prevent misdiagnosis of these
cases as reactive lymphadenitis by comparing the serum adenosine deaminase
levels. This study will significantly help in reducing further infection, severity and
spread of infection in the community.
6.2) REVIEW OF LITERATURE
Tuberculosis has emerged as one of the most lethal diseases man has ever faced.
In a short span of time, it has become a major health problem in the developing
countries. No other disease has so much socioeconomic health significance as
tuberculosis in a country like India1. India accounts for nearly one third of global
burden of tuberculosis2.
Tuberculosis is a social disease with medical aspects. It has also been
described as a barometer of social welfare. The social factors include many non
medical factors such as poor quality of life, poor housing, population explosion,
under nutrition, lack of education, large families, early marriages, lack of
awareness of causes of illness2, etc.
Tuberculosis usually affects the lungs, but extra pulmonary tuberculosis is of
equal importance of which tuberculous lymphadenitis is the most common.
Diagnosis of tuberculous lymphadenitis is confirmed routinely by fine needle
aspiration cytology and AFB staining.
Adenosine deaminase is an enzyme required for converting adenosine to
inosine in the purine salvage pathway. Its activity is involved in the differentiation
and proliferation of lymphocytes and activation of macrophages. This enzyme is
important in the rapid proliferation of cells to prevent the accumulation of toxic
metabolite. Adenosine deaminase activity increases during cellular activation to
detoxify toxic metabolite3.
An increase in serum adenosine deaminase activity has been described in
several diseases such as pulmonary tuberculosis, typhoid fever, infectious
mononucleosis and brucellosis. Adenosine deaminase has been proposed to be
useful marker for tuberculosis in pleural, pericardial and peritoneal fluids1.
6.3) OBJECTIVES OF THE STUDY
1. To assess the diagnostic significance of serum adenosine deaminase levels

in fine needle aspiration cytology confirmed cases of tuberculous lymphadenitis
and to determine its sensitivity and specificity.
2. To rule out early tuberculosis in cases reported by fine needle aspiration
cytology as reactive lymphadenitis.
7) MATERIALS AND METHODS
7.1: SOURCE OF DATA: The patients with clinically suspected tuberculous

lymphadenitis and reactive lymphadenitis undergoing fine needle aspiration
cytology in the department of Pathology, Victoria hospital and Bowring and Lady
Curzon hospitals.
7.2: METHODS OF STUDY:
PEREIOD OF STUDY
Nov 2010 to Oct 2012
STUDY DESIGN
Cross-sectional and analytical studies
SAMPLE DESIGN
Purposive sampling
SAMPLE SIZE
100 patients with clinical suspicion of tuberculous lymphadenitis and reactive

lymphadenitis.
7.3: INCLUSION CRITERIA:
1. Patients of either sex and of any age who are referred for fine needle aspiration
cytology of peripheral lymph nodes with clinical suspicion of tubercular
lymphadenopathy or reactive lymphadenopathy.
2. Patients who are on anti tubercular therapy with cervical lymphadenopathy.
3. Patients who are positive for tuberculous lymph node or reactive lymph nodes
and given consent for serum adenosine deaminase level estimation.
7.4 EXCLUSION CRITERIA:
Diagnosed cases of acute lymphadenitis, infectious mononucleosis, enteric

fever, leprosy, hepatitis A & B, chickenpox, hematopoietic malignancies
like Hodgkin’s lymphoma and drug induced lymphadenitis.
7.5 METHODOLOGY:
After obtaining approval and clearance from the institution ethical

committee, patients will be included for the study.
The study subjects fulfilling the inclusion and exclusion criteria of
the study are first diagnosed by fine needle aspiration cytology and AFB staining.
This is followed by the measurement of serum adenosine deaminase levels. A
normal range for serum adenosine deaminase levels is 5-35 IU/l. The results are
recorded in the study proforma. Later the diagnosed cases are confirmed by
histopathological examination.
7.6 ASSESSMENT TOOLS:
1. A thorough history taking and physical examination mainly focused on

tuberculosis and the risk factors for tuberculosis.
2. Fine needle aspiration cytology smears for the features of granulomas,
multinucleated giant cells and AFB which suggest tubercular lymphadenitis.
3. Serum adenosine deaminase levels done by calorimetric method.
4. Lymph node biopsy confirmation for tuberculosis.
7.7 THE DETAILED SCHEDULE OF PATIENTS VISIT:
Visit 1/ day 1
Patients with inclusion and exclusion criteria will be taken thorough history
related to tuberculosis and detailed physical examination is conducted to elicit the
signs of tuberculosis.
Fine needle aspiration cytology is done in the peripheral lymph nodes and
the smear is spread on slides.
The smears are stained by Giemsa, PAP, AFB and fluorescent stains and
examined under the microscope for the features of tubercular lymphadenitis or
reactive lymphadenitis.
Written informed consent will be taken from the patients for serum
adenosine deaminase and blood is collected in a plain tube.
Adenosine deaminase estimation is done by calorimetric method and the
results are tabulated.
Visit 2/ day 2
A contact detail of all cases of tubercular lymphadenitis and reactive
lymphadenitis are registered.
Patients with tubercular lymphadenitis by fine needle aspiration cytology
are advised for lymph node biopsy for confirmation as a gold standard.
Patient with reactive lymphadenitis and elevated serum adenosine
deaminase levels are asked for follow-up at a later date for repeat fine needle
aspiration cytology of lymph nodes for the presence of residual disease and
adenosine deaminase levels.
All the positive cases will be referred to RNTCP for timely and appropriate
treatment.
7.8 STATISTICAL METHODS: The data in the study is analyzed by
determination of sensitivity, specificity, positive predictive value and negative
predictive value for serum adenosine deaminase levels in tuberculous
lymphadenitis.
7.9(A) Does the study require any investigation or interventions to be
conducted on patients or other human or animals? If so describe briefly
It does not require any animal studies.

The following are the investigations that are done on study subjects.
1. Fine needle aspiration cytology of lymph nodes
2. Serum adenosine deaminase( ADA) estimation
3. Lymph node biopsy
7.9(B) Has the ethical clearance been obtained from your institution?
Submitted for approval

8 LIST OF REFFERENCE.
1. Verma M, Narang S, Moonat A, Verma A: Study of adenosine deaminase

activity in pulmonary tuberculosis and other respiratory diseases. Indian Journal of
Clinical Biochemistry 2004; 19(1): 129-131.
2. Park K: Park’s textbook of preventive and social medicine. 18 th ed. Jabalpur,

M/s Banarsidas Bhanot 2005; 147-150.
3. Lumsal M, Goutham N, Bhatt N, Majhi S, Baral N, Bhattacharya SK:

Diagnostic utility of adenosine deaminase activity in pleural fluid and serum of
tuberculous and non-tuberculous respiratory disease patients. Southeast Asian J
Trop Med Public Health 2007; 38: 363-369.
4. Sharma SK, Suresh V, Mohan A, Kaur P, Saha P, Kumar A et al: A prospective

study of sensitivity and specificity of adenosine deaminase estimation in the
diagnosis of tuberculosis pleural effusion. Indian J Chest Dis Allied Sci 2001;
43(3): 149-55.
5. Mathur PC, Tiwary KK, Trikha S, Tiwary D: Diagnostic value of adenosine

deaminase activity in tubercular serositis. Indian J Tuberc 2006; 53: 92-95.
6. Takayuki Morisaki MD, Hisaichi F, Shiro M: Adenosine deaminase in

leukemia: Clinical value of plasma adenosine deaminase activity and
characterization of leukemic cell adenosine deaminase. Am J Hematology 1985;
19(1): 37-45.
7. Cesar S, Sunguroglu K, Ahmed K, Teheran D, Keseci NO, Aksaray S: Serum

adenosine deaminase levels in patients with brucellosis and in healthy subjects.
Turk J Med Sci 2004; 34: 315-318.
9) SIGNATURE OF THE CANDIDATE:
(DR.JAYAKUMAR.C.K)
10) REMARKS OF THE GUIDE:
11) NAME AND DESIGNATION OF
11.1 GUIDE: DR. SIDDIQ M AHMED, MD

Professor
Department of Pathology,
Bangalore Medical College &
Research Institute,
Bangalore.
11.2 SIGNATURE:
11.3 CO-GUIDE:
11.4 SIGNATURE:
11.5 HEAD OF THE DEPARTMENT: DR. A.H.NAGARAJAPPA,M.D

Professor and H.O.D,
Department of Pathology,
Bangalore Medical College &
Research Institute,
Bangalore.
11.6 SIGNATURE:
12) 12.1) REMARKS OF THE CHAIRMAN AND PRINCIPAL:
12.2) SIGNATURE:

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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

SYNOPSIS FOR REGISTRATION OF SUBJECT FOR

1 NAME OF THE CANDIDATE Dr. JAYAKUMAR.C.K

2 NAME OF THE INSTITUTION BANGALORE MEDICAL

3 COURSE OF STUDY & M.D. IN PATHOLOGY

4 DATE OF ADMISSION TO 24 MAY 2010

5 TITLE OF THE TOPIC “STUDY OF SERUM

6 BRIEF RESUME OF THE INTENDED WORK:

6.2) REVIEW OF LITERATURE

6.3) OBJECTIVES OF THE STUDY

1. To assess the diagnostic significance of serum adenosine deaminase levels

7) MATERIALS AND METHODS

7.1: SOURCE OF DATA: The patients with clinically suspected tuberculous

7.2: METHODS OF STUDY:

Nov 2010 to Oct 2012

Cross-sectional and analytical studies

100 patients with clinical suspicion of tuberculous lymphadenitis and reactive

7.3: INCLUSION CRITERIA:

2. Patients who are on anti tubercular therapy with cervical lymphadenopathy.

7.4 EXCLUSION CRITERIA:

Diagnosed cases of acute lymphadenitis, infectious mononucleosis, enteric

After obtaining approval and clearance from the institution ethical

1. A thorough history taking and physical examination mainly focused on

7.7 THE DETAILED SCHEDULE OF PATIENTS VISIT:

7.8 STATISTICAL METHODS: The data in the study is analyzed by

determination of sensitivity, specificity, positive predictive value and negative

predictive value for serum adenosine deaminase levels in tuberculous

7.9(A) Does the study require any investigation or interventions to be

conducted on patients or other human or animals? If so describe briefly

It does not require any animal studies.

Submitted for approval

1. Verma M, Narang S, Moonat A, Verma A: Study of adenosine deaminase

2. Park K: Park’s textbook of preventive and social medicine. 18 th ed. Jabalpur,

3. Lumsal M, Goutham N, Bhatt N, Majhi S, Baral N, Bhattacharya SK:

4. Sharma SK, Suresh V, Mohan A, Kaur P, Saha P, Kumar A et al: A prospective

5. Mathur PC, Tiwary KK, Trikha S, Tiwary D: Diagnostic value of adenosine

6. Takayuki Morisaki MD, Hisaichi F, Shiro M: Adenosine deaminase in

7. Cesar S, Sunguroglu K, Ahmed K, Teheran D, Keseci NO, Aksaray S: Serum

10) REMARKS OF THE GUIDE:

11) NAME AND DESIGNATION OF

11.1 GUIDE: DR. SIDDIQ M AHMED, MD

11.5 HEAD OF THE DEPARTMENT: DR. A.H.NAGARAJAPPA,M.D

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