Download Dr. ASHA.ML MDS

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
NAME OF THE CANDIDATE AND
Dr. VINI J. KANCHAN,
ADDRESS (IN BLOCK LETTERS)
POST GRADUATE STUDENT,
SRI HASANAMBA DENTAL
COLLEGE AND HOSPITAL,
VIDYANAGAR,
HASSAN-573201, KARNATAKA.
2.
NAME OF THE INSTITUTION
SRI HASANAMBA DENTAL
COLLEGE AND HOSPITAL,
VIDYANAGAR,
HASSAN-573201
KARNATAKA
3.
COURSE OF STUDY AND SUBJECT
MASTER OF DENTAL SURGERY IN
ORAL MEDICINE AND RADIOLOGY.
4.
DATE OF ADMISSION TO COURSE
31 - 05 - 2011
“COMPARATIVE STUDY OF
5.
TITLE OF THE TOPIC
SERUM IgA LEVEL IN PRE AND
POST TREATED ORAL CANCER
PATIENTS.”
6.
BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Oral squamous cell carcinoma (OSCC) is the sixth most common cancer worldwide,
accounting for between 90 to 95% of all malignancy of mouth1. It is necessary for the
discovery of immunological markers at a clinical, histological and molecular level to
significantly reduce mortality2.
The term “tumor marker” is applied to indicate the risk, presence, status or future
behavior of cancer. Serum immunoglobulin serves as a link between epitopes on tumor
cell antigens and the host-effecter cells. Recent studies have reported that there is a
significant elevation in serum IgA concentration of patients with oral squamous cell
carcinoma, which reduces immediately after treatment during the follow up period.
Also the serum IgA concentration is consistent with progression of the disease and
recurrence. Therefore, the following study is undertaken, with a purpose to evaluate
and compare serum IgA level in pre and post treated oral squamous cell carcinoma
patients3.
6.2 Review of Literature:
1. Ashley M. Brown et al in 1975 conducted a study to correlate association in
IgA levels in saliva and serum with the progression of oral cancer. Where they
took whole saliva and sera of 102 cases of oral squamous cell carcinoma. They
reported that saliva and sera IgA levels are elevated in primary oral cancer,
salivary IgA return to normal after 9 months of treatment and serum IgA
maintained higher levels, whereas the serum IgA were found to re-elevate with
recurrence of oral cancer4.
2. K. Vinzenz, R. Pavelka et al in 1986, conducted a study on serum
immunoglobulin levels in patients with head and neck cancer (IgA, IgE, IgM,
and IgG). In the study, 226 patients with squamous cell cancer of the head and
neck, who had undergone no antitumor therapy, were examined pre
therapeutically for serum immunoglobulin levels. They concluded that in
cancer patients, significant elevations of mean levels of IgA and IgE were
found in comparison to normal healthy controls. The group of patients with
relapse in the follow up was found to have therapeutically significant higher
levels of both IgA and IgE in comparison to those without evidence of disease
for more than 6 months. These results point to the fact that determination of
serum IgA and IgE in patients with head and neck cancer might be applicable as
parameters for monitoring malignant disease, being additionally of some
prognostic significance5.
3. Vijayakumar et al in 1986 conducted a study to compare serum
immunoglobulin in patients with carcinoma of the oral cavity, uterine cervix
and breast, where they took 196 patients with oral cancer, 172 patients with
cervical cancer and 166 patients with breast cancer. They found out that serum
IgA, IgD and IgE levels were found to be elevated in all the three types of
cancers and the levels were found to increase with clinical stage.
Immunoglobulin A and D returned to normal after clinical cure of the disease6.
4. Crispian Scully in 2005, conducted a study on immunological abnormalities in
oral carcinoma and oral keratosis. Examination of serum concentrations of IgG,
IgA, IgM, IgE and IgD in oral carcinoma confirmed a rise in serum IgA
concentration in oral carcinoma, whereas other serum immunoglobulins were
found to be in normal concentrations. The results may reflect changes in cellmediated immunity rather than simply changes in humoral immunity7.
5. Sameena Parveen et al in 2010 conducted a study, which deals with the
estimation of circulating immune complex (CIC) and immunoglobulin levels
IgG, IgA, IgM in both pre-treatment and post-treatment phases, with follow-up
period of 3 to 24 months in patients with oral cancer. The malignancy group
consisted of 56 patients with different stages of oral cancer and 20 healthy
control groups. They noted an increased CIC level with progression of
malignancy and also serum immunoglobulin levels, especially IgA, increases
with progression of disease state. Serum concentration of IgA was increased in
patients with oral cancers, as IgA is the predominant immunoglobulin secreted
into the mucosal surface of nose, mouth, stomach, intestine, lungs, tears and
colostrums. The serum IgA level is increased also due to the local immune
response to the antigenic stimulation of the tumor3.
6.3 OBJECTIVES OF THE STUDY:
1) To assess serum IgA levels in:
Group A (pre treated cancer patients)
Group B (post treated cancer patients)
Group C (control group)
2) Comparison of serum IgA levels in pre and post treated oral cancer patients
with that of control group.
7.
MATERIALS AND METHODS :
7.1 Source of data:
This study will be conducted on 40 patients; 15 pre treated cancer patients, 15 post
treated patients, and 10 healthy individuals. Cancer patient will be included from
patients reporting to; Hassan cancer center, Kandhali and Preethi Cancer Institute,
Mysore. Healthy individuals will be taken from Hasanamba Dental College; Hassan.
Materials:
A) Disposable, single use, 21 gauge needle or 22 gauge needle.
B) Disposable, single use, needle holder
C) Evacuated blood tubes
D) Disposable tourniquet (non-latex)
E) Sterile alcohol preps or betadine (povidone-iodine) swab
F) Disposable gloves (non-latex)
G) Sharps container
H) Sterile gauze pads
I) Sterile band aid/ surgical tape/ paper adhesive tape
7.2 Method of collection of data:
The data will be obtained from those subjects satisfying the criteria, as listed below.
INCLUSION CRITERIA:
1) Age range: 35 – 65 yrs.
2) Group A consists of patients of biopsy confirmed oral squamous cell
carcinoma, who have received no medical treatment.
3) Group B consists of post treated oral cancer patients, reviewed after 3 months
of treatment.
4) Group C consist of normal healthy individuals.
EXCLUSION CRITERIA:
1) Metastatic tumors in the oral cavity.
2) Patients with carcinoma of other parts of the body.
3) Control group with compromising systemic conditions and neoplastic disorders.
PROCEDURE:
All the participants will be given brief information about the purpose of the study and
written consent will be taken with signature from the subjects before undertaking the
study.
Group A consisting of 15 patients diagnosed with squamous cell carcinoma of oral
cavity, with histopathological confirmation and grouped according to AJCC TMN
stages.
Group B consisting of 15 treated tumor patients those who had been free of tumor for 3
months. All were treated either by surgery, radiation, chemotherapy or a combination
of all.
Group C consisting of 10 healthy individuals within the selected age group.
10 ml of venous blood samples are collected from the antecubital vein of all the pre and
post treated oral cancer patients and normal individuals, in blood tubes with EDTA as
anticoagulant. Samples will be delivered to the laboratory for the estimation of serum
IgA level by nephalometry method by the histopathologist.
Statistical Analysis :
Data will be collected and statistically analyzed.
7.3. Does the study require any investigations or interventions to be conducted on
patients or other humans or animals? If so please describe briefly.
YES
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES
.
8.
LIST OF REFERENCES:
1. Pérez-Sayáns M, Somoza-Martín JM, Barros-Angueira F, Reboiras-López MD,
Gándara Rey JM and García-García A. Genetic and molecular alterations in
oral squamous cell carcinoma. Oncol reports 2009; 22: 1277-1282.
2. Khanna SS and Karjodkar FR. Circulating immune complexes and trace
elements (copper, iron and selenium) as markers in oral precancer and cancer: a
randomized, controlled clinical trial. Head face med 2006; 2(33)
doi:10.1186/1746- 160*-2-33.
3. Parveen S, Taneja N, Bathi RJ and Deka AC. Evaluation of circulating immune
complexes and serum immunoglobulins in oral cancer patients- A follow up
study. Ind J Dent Res 2010; 21(1): 10-15.
4. Browns AM, Lally ET, Frankel A, Harwick R Davis LW and Rominger CJ
Serum and saliva IgA in oral cancer. Cancer 1975; 35: 1154-1162.
5. Vinzenz k, Pavelka, Schönthal E, Zekert F. Serum immunoglobulin levels in
patients with head and neck cancer (IgE, IgA, IgM, IgG). Oncol 1986; 43: 316322.
6. Vijayakumar T, Ankathil R, Remani, Sasidharan VK, Vijayan KK, Vasudevan
DM. Serum immunoglobulins in patients with carcinoma of the oral cavity,
utrine cervix and breast. Cancer Immunol Immunother 1986; 22: 76-79.
7. Scully C. Immunological abnormalities in oral carcinoma and oral keratosis. J
Maxillofac Surg 1982; 10: 113-115.
9.
SIGNATURE OF THE CANDIDATE
( Dr. VINI J. KANCHAN )
10.
REMARKS OF THE GUIDE
11.
NAME & DESIGNATION OF
(IN BLOCK LETTERS)
11.1 GUIDE
Dr. ASHA M.L M.D.S
PROFESSOR AND HEAD,
DEPARTMENT OF ORAL MEDICINE
AND RADIODIAGNOSIS,
SRI HASANAMBA DENTAL COLLEGE
AND HOSPITAL,
HASSAN-573201.
11.2 SIGNATURE
11.3 CO-GUIDE (IF ANY)
11.4 SIGNATURE
11.5 HEAD OF THE DEPARTMENT
Dr. ASHA.M.L M.D.S
PROFESSOR AND HEAD,
DEPARTMENT OF ORAL MEDICINE
AND RADIODIAGNOSIS,
SRI HASANAMBA DENTAL COLLEGE
AND HOSPITAL,
HASSAN – 573201.
11.6 SIGNATURE
12.
REMARKS OF THE CHAIRMAN
& THE PRINCIPAL
12.1 SIGNATURE
Dr. S. RAVINDRA M.D.S.
PRINCIPAL,
SRI HASANAMBA DENTAL COLLEGE
AND HOSPITAL,
HASSAN – 573201.