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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.