Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

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
COLLEGE
26-05-2010
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
N=
{( p1q1+p2q2 ) ( zα+zβ ) 2 }
(p1-p2)2
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
11. REMARKS OF THE GUIDE
A carcinoma cervix worldwide account for
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,
Dept of Community Medicine,
MSRMC,Bangalore-54
SIGNATURE
12.3 HEAD OF DEPARTMENT
Dr.Pruthvish.S. MD,DNB.
Professor and HOD
Dept of Community Medicine,
MSRMC Bangalore-54
SIGNATURE
12.4 REMARKS OF CHAIRMAN AND
PRINCIPAL
SIGNATURE