Rajiv Gandhi University of Health Sciences, Bangalore s4

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

KARNATAKA.

REGISTRATION OF SUBJECT FOR DISSERTATION

Dr. Swapna.M

D/0 Maranna.K 1.NAME OF THE CANDIDATE AND ADDRESS #88, 4TH cross Lalbagh Road,

Near Myschool,

Bangalore:560027.

2.NAME OF THE INSTITUTION M.S.Ramaiah Medical College

M.S.Ramaiah Nagar,

MSRIT Post, Bangalore-560054.

3.COURSE OF STUDY AND SUBJECT M.D.Community Medicine.

4.DATE OF ADMISSION TO THE 26-05-2010 COLLEGE

5.TITLE OF THE TOPIC A study to assess selected risk factors

for carcinoma cervix among patients

attending Kidwai Memorial Institute of

Oncology, Bangalore. 6. BRIEF RESUME OF THE INTENDED WORK

6.1.INTRODUCTION:

Non-communicable diseases are assuming increasing importance among the adult population in both developed and developing countries. Cardiovascular disease and Cancer are at present the leading cause of death in developed countries, accounting for 70-75% of total deaths.1

The prevalence of non-communicable disease is increasing due to increasing life expectancy, change in life style and behavioral pattern of people and improved medical care.2

Nearly 12.7 million new cancer cases and 7.6 million cancer deaths occurred in 2008 worldwide.3 Cervical Cancer is an important public health problem worldwide, it is second most common cancer among women globally and ranking first in many developing countries.4 World wide it affects about 16/100,000 women per year and kills about 9/100,000 per year globally.3

Developing countries account for 80% of cervical cancer, where as in affluent countries, Cancer cervix does not find place even in top five cancers in women.5

The incidence and mortality in the developed countries are about half of those for the rest of the world which is due in part to success of screening with Pap smear. Cervical cancer is potentially the most preventable and treatable cancer in human but it is the leading cause of cancer morbidity and mortality in women around the world.

The incidence of cervical cancer for the year 2008 in India was 134,420, and mortality was

72,825.6 The age adjusted incidence rate for cancer cervix in Bangalore was 18.8 /100,000 population.7 Therefore more innovative prevention and treatment protocols need to be developed and implemented with better understanding of the etiology of the disease, specific prevention protocol that involve life style modification to minimize the impact of environmental risk factor can be developed.

6.2.NEED FOR THE STUDY:

Evidence for association between cervical cancer and various risk factors are widely published and documented in literature, however evidence of studies from Karnataka are limited. With demographic and epidemiological transition resulting from various factors, alterations in nature and frequency of known epidemiological determinants for cervical cancer would be expected.

The investigators strongly feel the need for contributing to the pool of existing evidence of these expected epidemiological determinants for cervical cancer.

The study could provide insights into the nature, quantum and strength of association of risk factors commensurating to the grade of cervical cancer studied.

This present study may provide vital information regarding the risk factors, strength of associations which would help to plan and formulate appropriate interventions, for control of cervical cancer in the State.

6.3 RESEARCH QUESTION:

What is the association between selected risk factors and carcinoma cervix among patients attending Kidwai Memorial Institute of Oncology, Bangalore?

6.4 OBJECTIVES:

1. To study the association between selected risk factors and carcinoma cervix among patients attending Kidwai Memorial Institute of Oncology, Bangalore.

6.5. REVIEW OF LITERATURE:

In a study done by Franceschi et al in Chennai (2003), India reported that Human papilloma virus infection was confirmed to be a necessary event for the development of cervical carcinoma with an odds ratio of 498, high parity>4 with odds ratio7.3 when compared with a parity<2, women reporting of their husband’s extra marital sexual relationship, being a risk factor with odds ratio being 10.8

A study by Misra in Lucknow (2009), India reported an increase in frequency of carcinoma cervix with increasing age beyond 40yrs of age and with increasing parity highly significant between Para 2 and 3.5

A study by Murthy et al in New Delhi (1990), India reported that the relative risk for age at consummation of marriage, literacy status of women and total number of pregnancies were found to be statistically significant. Women with consummation of marriage before 18yrs had a 2.8 fold higher risk of development of cervical cancer as compared to women over 18yrs.Similarly, increasing number of pregnancies carried a higher risk and associated relative risk was 1.1.The illiterate women had 1.74 times risk for development of cervical cancer than literate women.9

In a study done by Biswas et al in Calcutta (1997), India showed that age at first intercourse at 12 yr of age was a risk factor for carcinoma cervix with an odds ratio of 3.5 when compared to age at first intercourse at 18yrs, and increased risk was also seen with women who had extramarital affair with an odds ratio of 5.5.10 In a study done by Monali, Bhardwaj, Vadodara, India(2004), showed that male factor such as poor genital hygiene, alcoholism, tobacco use and multiple sexual partners increase the risk of cervical cancer in their female partners. Education, use of condoms, circumcision can help to reduce the risk.11

In a study done by Agarwal et al in New Delhi (1993), India showed that premarital sexual relationship and extramarital sexual relationship of husbands were considered as risk factors, with a relative risk of 1.9 and 2.7 respectively, and sex with uncircumcised men increased the risk of cervical cancer with a relative risk of 4.1.12

7. MATERIAL AND METHODS:

7.1 STUDY SETTING:

Kidwai Memorial Institute of Oncology, Bangalore.

This is an autonomous, nonprofit institution with an inpatient bed strength of 450.Annually around 14,000 new cases are registered and over 200,000 follow up visits are recorded. This institute has a PBCR (population based cancer registry) since 1982 and a HBCR (hospital based cancer registry) since 1984 and both are under NCRP (national cancer registry programme). The institute has a multidisciplinary approach for diagnosis and treatment and offers all modalities of treatment, surgery, radiotherapy, chemotherapy and hormonal therapy. In view of facilities available at the institute at concessional rates, patients all over Karnataka as well from adjoining areas of neighboring states attend the hospital.

7.2 STUDY POPULATION:

Cases: Newly diagnosed and histologically confirmed cases of cervical cancer, above 30 yrs age, including all stages of disease, attending Kidwai Memorial Institute of Oncology Bangalore. Controls: For each case one control will be selected (1:1) for whom 5yr age class interval will be matched, controls will be hospital attendees.

Hospital attendees: Apparently healthy attendants of cases either relatives or friends attending the hospital.

Inclusion criteria:

 Histologically confirmed newly diagnosed cases of cancer cervix, above 30yrs of age

including all stages of the disease, who are willing to participate.

 No previous treatment for any kind of malignancy.

Exclusion criteria:

 Patient diagnosed with other gynecological cancers (i.e., vagina, vulva, cancer of

endometrium, ovary and breast)

 Adenocarcinoma of cervix.

 Metastatic cases of cervical cancer.

 Individuals who are not able to respond coherently to the question asked.

7.3 STUDY DESIGN:

Case control study.

7.4 STUDY INSTRUMENT:

Pre-designed, semi structured, standardized questionnaire will be administered

7.5 SAMPLING TECHNIQUE: Purposive sampling

7.6 STUDY PERIOD:

1 year from Feb 2011- Jan 2012.

7.7 METHODOLOGY:

Necessary Permission would be sought from the concerned authorities in Kidwai Memorial

Institute of oncology, for the study. .

Informed oral consent will be taken from both the cases and controls, for each case one control will be selected. The cases and controls will be age matched with 5yr age class interval.

Semi-structured questionnaire will be developed and standardized following pilot study. The questionnaire will be administered to both cases and controls.

Information regarding the sociodemographic factors and risk factors will be collected from cases and controls.

Sociodemographic factors will include: Age, Literacy status, Marital status, occupation and income.

Age: this variable is ascertained using the available records (Voters ID card, Ration card)

Socioeconomic status and education is ascertained using modified kuppuswamy’s classification. Information about risk factors like age at consummation of marriage, parity, smoking, oral contraceptive usage, genital hygiene, condom usage by male partners and number of sexual partners, among cases and controls would be obtained.

8. Sample size:

200 cases and 200 controls.

A study carried out in Chennai, to elicit the risk factors for invasive cervical cancer cases, revealed that 45.6% of cases and 33% of controls had age at first intercourse, before the age of

17 yrs8 ,since the age at start of sexual activity is one of the main risk factors for development of cancer cervix, the findings from the above article has been utilized for estimating the sample size for the present study.

Sample size was estimated using N master software. The formula used is

2 N= {( p1q1+p2q2 ) ( zα+zβ ) }

2 (p1-p2) Where

p1=proportion among the cases, p2= proportion among the controls

q1=(1-p1),q2=(1-p2)

zα= alpha error, zβ = beta error

The estimated sample size was approximated to 200cases and 200 controls, with an alpha error of 10% and keeping the power of the study to be 80%.

8.1 ANALYSIS OF THE DATA The data will be tabulated for the various risk factor being studied, Further all the quantitative variable as age, parity etc, will be summarized in terms of mean, median, etc; to understand the variation with the quantitative variable standard deviation will be calculated.

The strength of association for various risk factors between cases and controls is estimated using odds ratio with 95% confidence interval. To evaluate the independent risk factor associated with the development of carcinoma cervix, multiple logistic regression analysis will be attempted.

9. REFERENCES :

1. Park K, Park’s text book of Preventive and Social Medicine, Jabalpur; M/S Banarsidas

Bhanot publishers, 2005, 18thedition.

2. Juneja A, Sehgal A, Mitra AB, Pandey A. A Survey on Risk Factors Associated with

Cervical Cancer.Indian Journal of Cancer 2003;40(1):15-22.

3. The International Agency for research and Cancer, GLOBOCAN 2008, an online

resource for cancer statistics.www.uicc.org/general-news/globocan-2008 accessed on

12/8/2010. 4. Parkin DM, Freddie J, Ferlay, Pisani P. Global Cancer Statistics, Cancer J Clin 2005;

55:74-108.

5. Misra JS, Srivasta S, Singh U, Srivastava AN. Risk factors and strategies for control

ofcarcinoma cervix in India: Hospital based cytological screening experience of 35yrs:

Indian journal of cancer 2009;46:155-59 .

6. Shantha V, Krishnamurthi S, Gajalakshmi CK, Swaminathan R, Ravichandran K.

Epidemiology of cancer cervix: Global and national perspective. J Indian Med Assoc

2000; 98: 49-52.

7. National cancer registry programme. Time trends in cancer Incidence rates 1982-2005.

Bangalore NCRP; 2009

8. Silvia Franceschi et al.Human Papilloma Virus and Risk Factors for Cervical Cancer in

Chennai, India: A Case Control Study. Int J.Cancer 2003; 107:127-33.

9. Murthy NS, Segal A, Satyanarayana L, Das DK ,Singh V, Das BC, Gupta MM, Mitra AB

and Luthra UK.Risk factors related to biological behavior of precancerous lesion of the

uterine cervix. Br. J. Cancer 1990;61:732-36. 10. Biswas LN, Manna B, Maiti PK, Sengupta S. Sexual risk factor for cervical cancer

among rural India women. International Journal of Epidemiology 1997;26(3):491-95.

11. Mondale D, Bhardwaj D.Male factor in carcinoma cervix. Obstet Gyneco Ind .

2004;54:583-85.

12. Agarwal SS et al. Role of male behavior in cervical carcinogenesis among women with

one life time sexual partner. Cancer 1993;72:166-69.

10 SIGNATURE OF THE CANDIDATE

A carcinoma cervix worldwide account for 11. REMARKS OF THE GUIDE 15% of all cancers diagnosed in women and is one of the leading causes of cancer death among women worldwide. The evidence from various studies suggests that cervical cancer is preventable. I strongly recommend this study by DR. Swapna

Dr. Suryanarayana. SP, 12.1 NAME AND DESIGNATION OF THE GUIDE Associate professor,

Dept of Community Medicine,

MSRMC,

Bangalore-54

SIGNATURE

Dr Ibhrahim Naganoor 12.2 NAME AND DESIGNATION OF THE CO-GUIDE I/C & Special Officer,

Dept of Community Oncology ,

Kidwai Memorial Institute of Oncology ,

Bangalore.29 . SIGNATURE

Dr. Suman.G CO-GUIDE Associate professor,

MSRMC,Bangalore-54 SIGNATURE

12.3 HEAD OF DEPARTMENT Dr.Pruthvish.S. MD,DNB.

Professor and HOD

MSRMC Bangalore-54

SIGNATURE

12.4 REMARKS OF CHAIRMAN AND PRINCIPAL

SIGNATURE