This document summarizes a proposed case-control study investigating risk factors for cervical cancer in Ethiopia. The study aims to identify socio-demographic, sexual, and reproductive health factors associated with cervical cancer. It will enroll 160 cervical cancer patients and 160 controls without cervical cancer visiting a gynecology clinic in Addis Ababa. Data will be collected through structured questionnaires and pap smears from controls. The results could help target high-risk groups for cervical cancer screening and inform local prevention practices.

1. Risk factors for cervical cancer in
Ethiopia
case control study
Investigator: Ethiopia Kumlachew
Adviser:Yirgu Gebrehiwot (M.D,M.Sc)
April ,2010 1

2. Statement of the problem
Cervical cancer-most common in developing
country
Although it is preventable disease it still
remains a major burden in sub-saharan
African country
Countries in this region has highest age
standardized death
Screening of high risk groups-reduction of
invasive cervical cancer
April ,2010 2

3. Pathways conceptual framework
Cervical
Cancer
HPV
Sexual
behaviour
Others
Reproductive
factor
Sociodemogaphic
factor
3
April ,2010

4. Significance of the study
Identification of risk factors will help
the prevention and control program
identifying risk factors will have a
paramount implication in identifying
target group
The result of this study can also help
as abase line data or source of
information for evidence based local
practice
April ,2010 4

5. April ,2010 5
Objectives
 General Objective
• To determine risk factors associated with cervical cancer
 Specific objectives
• To asses cervical cancer in relation to socio demographic factor
in Ethiopian context
• To determine the association of sexual behavior and cervical
cancer
• To asses reproductive factors related with cervical cancer

6. Methods and Materials
Study Area
Tikur Anbessa Hospital
• Only governmental referral hospital where
treatment and palliative care given
• Patients coming to this hospital can be
representative
April ,2010 6

7. continued
 Study Period
• The study period will be from April to August,
2010
 Study Design
• Case Control
 Reference population
• Ethiopian population
 Source population
• All gyn patients who visited TAH gyn opd
April ,2010 7

8. continued
A. Cases
1. All newly diagnosed precancerous and invasive
squamous cell cervical cancer patients
2.Those who provide consent to participate
B. Controls
1. Women visiting GOPD for other benign
tumors who are willing to have PAP test
2.PAP smear negative results
3.Those who provide consent to participate
April ,2010 8

9. Sample Size and Sampling
technique
 A double proportion sampling
 Sample size calculated using EPI6 stat-calc
 Age < 19 at first birth as a main predictor which is having
an incidence of occurrence 40% among the controls.
 Assumptions in sample size calculation are :
• To get a minimum OR of 2 among cases over controls
• 95% confidence interval;
• power of 80%
• ratio of 1:1 for cases and controls is taken
respectively.
• 10% nonresponse rate
 the sample size for cases and control will be 160:160
April ,2010 9

10. Data Collection Methods
 Structured questionnaire will be
prepared for both cases and controls
 The interview is going to be conducted
by the investigator and GYN-OBS
residents
 Pap smear is going to be collected
from control by the investigator and
GYN-OBS residents, to be done at
pathology department in BLH
April ,2010 10

11. VARIABLES
Dependent
Squamous cell carcinoma of the cervix
Independent
Age
Age at first intercourse
Age at first marriage
Parity,Abortion
Income
Education
Life time number of sexual partner
History of STD
Use of OCP
HIV status
Marital status
April ,2010 11

12. Data Entry and Analysis
Data will be entered after checking
completeness, using Epidate and analysis
will be done using stata
Ethical consideration
 The research protocol will be approved by the
research and publication committee of the
Department of GYNOBS, AAUMF. All ethical
issues will be taken into account. Data will be
collected after having voluntary consent from the
study subject
April ,2010 12

13. Budget
Interviewers / Data
collectors
Perdiem for data collectors Data collectors/interviewers
3 x 30days days X ETB
100.00 /day = 3,000.00
Pap test 160x44=7040ETB
Operational cost 1000.00ETB
TOTAL 11040.00
April ,2010 13

14. Work plan
April ,2010 14

15. References
1. Epidemiological status of cervical cancer , a report of WHO consultation 2002
2. Te Linde's operative Gynecology,10th ed,2008, Gynecology oncology, cancer of
the cervix, 1229-1232
3. Up-to-date version 16.3.cervical cancer screening and treatment in Africa and
other developing areas.2008
4. Berek & Novak’s Gynecology:14th ed.2007,cervical and vaginal cancer 1404-
1415
5. Chirenje, Z.M., et al., Situation analysis for cervical cancer diagnosis and
treatment in East, Central and Southern African countries. Bulletin of the World
Health Organization 2001. 79: p. 127-132.
6. Cancer advance in focus: cervical cancer-National Cancer Institute
7. Cancer Research UK: Cervical cancer risk factors
8. Role of parity and human papillomavirus in cervical cancer: the IARC
multicentric case-control study, Lancet; 2002 March 30,359(9312):1093-101
9. Report of the consultation on HPV vaccines, world health organization,
Geneva, April 2005
10. A study on determinants of invasive cervical cancer, by Shiferaw Negash,MD in
2000,AAUMF- unpublished
April ,2010 15

16. References
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Obstetrical and gynecological survey, cigarette smoking and human
papillomavirus in patients with Reported cervical cytological
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12. Screening for cervical intraepithelial neoplasia and cancer in the Sheffield STD
clinic, A B Alawattegama, Br J Vener Dis 1984;60:117-20
13. Sine Bayo,Fxavier Bosch,Silvia de sanjose,Nubia Munoz,Alba Lucia
combita,Pierre coursaget,Mireia Diza,Amardor Dolo,Adriaan JC Van den Burule
and Chris Jm Meijer,Risk factors of invasive cervical cancer in Mali, international
journal of Epidemiology 2002 ;31:202-209 national cancer institute, Oral
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Anne S.Whatley ,MS;Juddith A.Fortney,phD;Michele G.Bonhomme.MSPH,Oral
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15. Associations between smoking, screening and Death caused by cervical cancer in
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16. Combined effect of smoking and HPV type 16 infection in cervical carcinogenesis,
by Anne O.Olsen,Joakim Dillner,Anders Skrondal and per Magnus Epidemiology
© 1998 Lippincott Williams & Wilkins.
17. Smoking and cervical cancer, Joseph L. Lyon, A cancer J Clin 1984;34;302-303
April ,2010 16

17. References
18. Obstetrical and gynecological survey, June 1992 vol.47,No 6
19. A five years analysis of histological results of cervical biopsies examined in a
pathology department of a teaching hospital (2003-2007),by Balkachew Nigatu,MD-
unpublished
20. Determinants of clinical stage of presentation of invasive cervical cancer, cross-
sectional analysis at Tikur Anbessa Teaching Hospital, June 1 to August 31 ,2009,by
Yoseph Techane (MD)- unpublished
21. World Health Organization: Effective screening programmes for cervical cancer in low-
and middle Income developing countries, Bulletin of the World Health Organization,
Geneva, 2001, 79:954-96
22. Canadian medical association journal, cervical cancer, epidemiology, prevention and
the role of HPV infection , APR 3,2001;164(7)
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Mexico. Salud Publica Mex, 2008. 50(1): p. 49-58.
24. Adewuyi, S.A., S.O. Shittu, and A.H. Rafindadi, Sociodemographic and
clinicopathologic characterization of cervical cancers in northern Nigeria. Eur J
Gynaecol Oncol, 2008. 29(1): p. 61-4.
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15,461 women with cervical carcinoma and 29,164 women without cervical carcinoma
from 21 epidemiological studies. Cancer Epidemiol Biomarkers Prev, 2009. 18(4): p.
1060-9.
April ,2010 17

18. References
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among South African women. BMC Public Health, 2007. 7: p. 341.
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cytohistological abnormalities in uterine cervix]. Medicina (B Aires), 2006. 66(4): p. 303-6.
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infection by education level. Br J Cancer, 2009. 101(5): p. 865-70.
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8.
April ,2010 18

19. QUESTIONNAIRE ON RISK FACTORS OF CERVICAL
CANCER
 Socio-Demographic Characteristics
1. Age--- 2.Ethnicity-- 3. Region-
4. Place of residency
• a. urban
• b. rural
5. Religion-----------
6. Education
• a. Illiterate
• c. Elementary
• d. High school
• e. College/University
7. Marital status
• a. Single b. Married c. Divorced / separated d. Widowed
8. If the answer to question number 7 is other than single, then
answer
8.1 How many times you married----
8.2 How many times you divorced----
9. Occupation-------
10. Estimated monthly income----April ,2010 19

20. QUESTIONNAIRE ON RISK FACTORS OF CERVICAL
CANCER
B. Sexual and Reproductive health
1. Age at First Sexual Intercourse-----
2. Life time number of sexual partner----
3. Parity---
4. Number of Abortions
• 4.1 Spontaneous----
• 4.2 Induced-------
C. STD (yes or no)
1. History of abnormal vaginal discharge--------- 2. History of Genital Lesion--------
D. Use of any Kind of contraception
1. Pills 2.IUD 3.Condom
4. Injectable 5. Other (specify) -----
E. Duration of use for question number
F. indicate for each----
G. Only for cervical cancer cases
• 1. Presenting symptoms-----
• 2. Write clinical staging (Digital and speculum) -------
H. Only for controls write clinical diagnosis
April ,2010 20

21. Thank you
21