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Dr. Nisreen Anfinan
+
Cancer Incidence Report Saudi Arabia 2007. Available at www.scr.org.sa/reports/SCR2007.pdf Accessed on June 26, 2011
Prevalence: 2,274,000 women have cervical cancer1
Incidence: 510,000 new cases each year1
14,845
United States/Canada
49,025
South America
67,078
Africa
1,077
Australia/New Zealand
64,928
Europe
151,297
Southcentral Asia
+
Every year, 152 women are diagnosed with cervical cancer and 55 die from the disease.
new cervical cancer cases and deaths in 2025 are 309
1.9 cases per 100,000 women, accounting for 2.6% of diagnosed
cancer cases in women
Cancer Incidence Report Saudi Arabia 2007. Available at www.scr.org.sa/reports/SCR2007.pdf Accessed on June 26, 2011
+
Normal
Cervix
HPV
Infection
Cervical
Dysplasia
Cervical
Cancer
Primary
Prevention:
Vaccination
Secondary
Prevention:
Screening
+
 PAP smear
 VIA
 HPV testing
+
+
+
 Sensitivity of pap test to detect CIN3+: 55%.
 Should be done in the context of an organized screening
program.
 Quality assurance of cytology needs to be very good.
 System of communication to the women screened so that
they may receive sufficient treatment.
 Requires colposcopy and biopsy to confirm dysplasia.
 The necessity for multiple visits with cytology based.
 Screening results in significant loss to follow-up.
+
I f we don’t have establish screening
program for cervical cancer in low
resources setting
what you will use ??
Visual inspection of ascitic acid (VIA )
or
HPV testing
+
Budget for screening efforts is limited
Difficult access to health care
No follow up surveillance
Screening test need to be very sensitive
+
VIA: Visual inspection with acetic acid
VILI: Visual inspection with Lugols iodine
Both Low tech can be done by nurses
May need to utilize colposcopy to triage post positive test
to rule out cancer
+
TEST
SENSITIVITY
(%)
SPECIFICITY
(%)*
POSITIVE
PREDICTIVE
VALUE (%)*
NEGATIVE
PREDICTIVE
VALUE (%)*
VIA
(n = 2,130)
77
(70–82)
64
(62–66)
19 96
Pap smear
(n = 2,092)
44
(35–51)
91
(37–51)
33 94
University of Zimbabwe/JHPIEGO Cervical Cancer Project 1999.
+
Country Sensitivity Specificity
Arbyn, 2008 Africa & India 79.2 84.7
Sarian, 2005 Argentina & Brazil 50.0 89.7
Perez-Cruz, 2005 Mexico 14.3 97.3
Al Monte, 2007 Peru 41.2 76.7
Murillo, 2010 Colombia 53.6 93.2
Arbyn et al., IJC 2008; Sarian et al., JMedScreen 2005,
Perez-Cruz et al., SalpublicaMex 2005, Al Monte, IJC 2007,
Murillo et al., IJGO 2010
+
+
Triage equivocal or low grade cytology
smears (ALTS trial).
FUP of women with abnormal cytology
but normal colposcopy.
Predict outcome after treatment of high
grade disease.
Primary Screening.
Cuzick J. Vaccine 2008
+
CommentSpecificitySensitivityMethod
Easy, relatively inexpensive, but subjective,
insensitive, and nonspecific
LowCytology
Radioactive, commercially available as
ViraPap, ViraType, HPV Profile; labor intensive
ModerateDot blot
Rarely used todayLowFilter in situ hybridization
Detects HPV in paraffin-embedded tissueModerateIn situ hybridization
Gold standard but cumbersome; not feasible
for large-scale clinical use
HighSouthern blot hybridization
Newly approved for commercial use;
nonradioactive, easier to use and less
expensive than dot blot
HighHybrid capture
Uses amplification and so is prone to
contamination errors (false positive)
HighPolymerase chain reaction
Spitzer, Am J Obstet Gynecol, 1998
+
 More sensitive than pap smear
 Negative PV testing provides reassurance of not developing CIN3
over the next 5-10 years
 High HPV permits a safe and cost effective lengthing of the interval
5 years
 HPV test has an high NPV
 HPV test is ideally suited to reassure the negative HPV individual
and to increase interval between two subsequent screens
+
PAPHPV
55.6%94.6%Sensitivity
96.8%94.1%Specificity
Mayrand et al.;
compare the relative efficacy of HPV DNA testing and Pap cytology
in primary screening for cervical cancer and its high-grade precursors.
Pap screening followed by HPV (hc 2) vs hc2 testing followed by
HPV in women 30-69
 9,667 women
HPV testing is significantly more sensitive to detect CIN 2+
NEJM 2007
+
Sankaranarayanan,R:
Total of 131,746 healthy women
ages of 30 and 59 years
 RCT ,4 Arms of screening tool in India
 HPV test vs. Pap test vs. VIA vs. Observation
 Cervical cancer as an endpoint
 32000 women in each arm
 Screen positive received colposcopy and treatment
 Only significant screening method to reduce deaths from cervical
cancer was HPV testing
 Significant reduction in Ca Cervix in the HPV negative compared to
negative Pap and VIA
NEJM Apr2009 360(14)1385-94
+
National Programmers Pilot Studies
Argentina Germany Nicaragua
Mexico China Paraguay
The Netherlands Colombia Peru
USA El Salvador Georgia
Spain Rwanda
India Uganda
Italy United Kingdom
+
CYTOLOGY
Lab
Organizer
GP
Time/travel
Program
Total
Cost €
21.77
11.23
11.76
6.01
2.08
52.85
HPV
Lab
Organizer
GP
Time/travel
Program
Total
Cost €
33.83
11.23
11.76
6.01
2.08
64.9
BJOG. 2012 May;119(6):699-709. doi: 10.1111/j.1471-0528.2011.03228.x. Epub 2012 Jan 18
+
Proposal with help of international advisor and Local
Epidemiologist
Decision to use HPV testing HC2 (high risk) in collaboration
of local virology lab
Design unique data base for the program with recalling
system
Quality assurance and frequent monitoring
+
Targeted Population:
There are a total of 944816 women at age of 30-65
in Jeddah region.
Married for 3 yearr ??
+
Dr. Nisrin Anfinan
Early Detective
Unit and JCSP Coordinator
Rowaida Al Mehy
GOU Secretary
Maribi Marqueses
GOU Office Assistant
Dr. Faten Gazzaz
Director of
Virology Laboratory
Eman Tayba
JCSP Laboratory Team
Aseel Alsobehi
JCSP Laboratory Team
Soheel Melebari
JCSP Laboratory Team
Prof. Jim Bentley
International Advisor
Prof. Khalid Sait
Director of Scientific Chair of Professor Abdullah
Hussain Basalamah
Prof. Abdullah Hussain Basalamah
General Advisor
+
Age 30-65 year.
Married for three years.
Saudi & non Saudi.
+
+
+
+
Use the high sensitivity of HPV test initially
Digene Hybrid capture 2 test is suitable
Positive HPV test has reflex pap testing
If both positive colposcopy is performed
If HPV neg repeat screen in 5 years
If HPV +ve and pap neg, repeat HPV and pap in 1 year
+
 Provider competency was maintained by medical
supervision in the field and by periodic supervision to monitor
their performance, along with
rates of positive results on screening, correlation
between colposcopy and histologic findings, and positive
predictive values for CIN.
 Internal and external quality-control measures were in place
for colposcopy and pathological analysis
+
Campaign (malls)
School (approval from ministry of education )
Media and news papers
+
collecting sampling in our
hospital )
+
Collecting Sample At
PHC
Collecting Sample In
Our Hospital
+
Collecting sample
at PHC
Collecting sample
in our hospital
Dr. Sami Badawwod
To start in 40 PHC in Jeddah
King Abdulaziz university
+
HPV self sampling
Collecting sample
at PHC
Collecting sampling
in our hospital
+
‫المركز‬‫السعودي‬‫للرعايه‬‫الصحيه‬‫المبنيه‬‫على‬‫البراهين‬
Guideline meeting for cervical cancer
screening
 Agreed among panel members that HPV testing will be
used as primary screening for cervucal cancer in SA
+
+
START DATE:
Total Number:
Our aim to achieve :
+
HR-HPV DNA in women 30 + years old
Negative
Negative
Negative
Pap test
Positive
Positive
Colposcopy
Positive
Repeat HR-DNA
testing @ 5 year
intervals till age
65
Repeat HR-
HPV testing at
12 months
+
0
50
100
150
200
250
300
350
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
10
22
98
148
168
56
30
18
46
196
330
212
New Registration for Year 2012
+
0
50
100
150
200
250
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
128
188
162
196
126
88
8
60
208
96
60
8
New Registration for Year 2013
+
0
50
100
150
200
250
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
4
14
54
108
154
48
16 14 22
152
218
144
6 8
44 40
14 8 14
4
24
44
112
68
New Registration for Year 2012 – Saudi vs. Non-Saudi
Saudi Non-Saudi
+
0
20
40
60
80
100
120
140
160
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
98
124
80
156
78
64
2
16
86
66
36
8
30
63
82
40 44
24
6
44
122
30
24
0
New Registration for Year 2013 – Saudi vs. Non-Saudi
Saudi Non-Saudi
+
In January 2014 will release
our positive HPV data.
Official opening of the
program will be hosted by
Dr. Khoshaim Mohmade.
+
National
Cervical
Screenin
Program

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Jcsp park hayat final ks

  • 2. + Cancer Incidence Report Saudi Arabia 2007. Available at www.scr.org.sa/reports/SCR2007.pdf Accessed on June 26, 2011 Prevalence: 2,274,000 women have cervical cancer1 Incidence: 510,000 new cases each year1 14,845 United States/Canada 49,025 South America 67,078 Africa 1,077 Australia/New Zealand 64,928 Europe 151,297 Southcentral Asia
  • 3. + Every year, 152 women are diagnosed with cervical cancer and 55 die from the disease. new cervical cancer cases and deaths in 2025 are 309 1.9 cases per 100,000 women, accounting for 2.6% of diagnosed cancer cases in women Cancer Incidence Report Saudi Arabia 2007. Available at www.scr.org.sa/reports/SCR2007.pdf Accessed on June 26, 2011
  • 5. +  PAP smear  VIA  HPV testing
  • 6. +
  • 7. +
  • 8. +  Sensitivity of pap test to detect CIN3+: 55%.  Should be done in the context of an organized screening program.  Quality assurance of cytology needs to be very good.  System of communication to the women screened so that they may receive sufficient treatment.  Requires colposcopy and biopsy to confirm dysplasia.  The necessity for multiple visits with cytology based.  Screening results in significant loss to follow-up.
  • 9. + I f we don’t have establish screening program for cervical cancer in low resources setting what you will use ?? Visual inspection of ascitic acid (VIA ) or HPV testing
  • 10. + Budget for screening efforts is limited Difficult access to health care No follow up surveillance Screening test need to be very sensitive
  • 11. + VIA: Visual inspection with acetic acid VILI: Visual inspection with Lugols iodine Both Low tech can be done by nurses May need to utilize colposcopy to triage post positive test to rule out cancer
  • 12. + TEST SENSITIVITY (%) SPECIFICITY (%)* POSITIVE PREDICTIVE VALUE (%)* NEGATIVE PREDICTIVE VALUE (%)* VIA (n = 2,130) 77 (70–82) 64 (62–66) 19 96 Pap smear (n = 2,092) 44 (35–51) 91 (37–51) 33 94 University of Zimbabwe/JHPIEGO Cervical Cancer Project 1999.
  • 13. + Country Sensitivity Specificity Arbyn, 2008 Africa & India 79.2 84.7 Sarian, 2005 Argentina & Brazil 50.0 89.7 Perez-Cruz, 2005 Mexico 14.3 97.3 Al Monte, 2007 Peru 41.2 76.7 Murillo, 2010 Colombia 53.6 93.2 Arbyn et al., IJC 2008; Sarian et al., JMedScreen 2005, Perez-Cruz et al., SalpublicaMex 2005, Al Monte, IJC 2007, Murillo et al., IJGO 2010
  • 14. +
  • 15. + Triage equivocal or low grade cytology smears (ALTS trial). FUP of women with abnormal cytology but normal colposcopy. Predict outcome after treatment of high grade disease. Primary Screening. Cuzick J. Vaccine 2008
  • 16. + CommentSpecificitySensitivityMethod Easy, relatively inexpensive, but subjective, insensitive, and nonspecific LowCytology Radioactive, commercially available as ViraPap, ViraType, HPV Profile; labor intensive ModerateDot blot Rarely used todayLowFilter in situ hybridization Detects HPV in paraffin-embedded tissueModerateIn situ hybridization Gold standard but cumbersome; not feasible for large-scale clinical use HighSouthern blot hybridization Newly approved for commercial use; nonradioactive, easier to use and less expensive than dot blot HighHybrid capture Uses amplification and so is prone to contamination errors (false positive) HighPolymerase chain reaction Spitzer, Am J Obstet Gynecol, 1998
  • 17. +  More sensitive than pap smear  Negative PV testing provides reassurance of not developing CIN3 over the next 5-10 years  High HPV permits a safe and cost effective lengthing of the interval 5 years  HPV test has an high NPV  HPV test is ideally suited to reassure the negative HPV individual and to increase interval between two subsequent screens
  • 18. + PAPHPV 55.6%94.6%Sensitivity 96.8%94.1%Specificity Mayrand et al.; compare the relative efficacy of HPV DNA testing and Pap cytology in primary screening for cervical cancer and its high-grade precursors. Pap screening followed by HPV (hc 2) vs hc2 testing followed by HPV in women 30-69  9,667 women HPV testing is significantly more sensitive to detect CIN 2+ NEJM 2007
  • 19. + Sankaranarayanan,R: Total of 131,746 healthy women ages of 30 and 59 years  RCT ,4 Arms of screening tool in India  HPV test vs. Pap test vs. VIA vs. Observation  Cervical cancer as an endpoint  32000 women in each arm  Screen positive received colposcopy and treatment  Only significant screening method to reduce deaths from cervical cancer was HPV testing  Significant reduction in Ca Cervix in the HPV negative compared to negative Pap and VIA NEJM Apr2009 360(14)1385-94
  • 20. + National Programmers Pilot Studies Argentina Germany Nicaragua Mexico China Paraguay The Netherlands Colombia Peru USA El Salvador Georgia Spain Rwanda India Uganda Italy United Kingdom
  • 22. + Proposal with help of international advisor and Local Epidemiologist Decision to use HPV testing HC2 (high risk) in collaboration of local virology lab Design unique data base for the program with recalling system Quality assurance and frequent monitoring
  • 23. + Targeted Population: There are a total of 944816 women at age of 30-65 in Jeddah region. Married for 3 yearr ??
  • 24. + Dr. Nisrin Anfinan Early Detective Unit and JCSP Coordinator Rowaida Al Mehy GOU Secretary Maribi Marqueses GOU Office Assistant Dr. Faten Gazzaz Director of Virology Laboratory Eman Tayba JCSP Laboratory Team Aseel Alsobehi JCSP Laboratory Team Soheel Melebari JCSP Laboratory Team Prof. Jim Bentley International Advisor Prof. Khalid Sait Director of Scientific Chair of Professor Abdullah Hussain Basalamah Prof. Abdullah Hussain Basalamah General Advisor
  • 25. + Age 30-65 year. Married for three years. Saudi & non Saudi.
  • 26. +
  • 27. +
  • 28. +
  • 29. + Use the high sensitivity of HPV test initially Digene Hybrid capture 2 test is suitable Positive HPV test has reflex pap testing If both positive colposcopy is performed If HPV neg repeat screen in 5 years If HPV +ve and pap neg, repeat HPV and pap in 1 year
  • 30. +  Provider competency was maintained by medical supervision in the field and by periodic supervision to monitor their performance, along with rates of positive results on screening, correlation between colposcopy and histologic findings, and positive predictive values for CIN.  Internal and external quality-control measures were in place for colposcopy and pathological analysis
  • 31. + Campaign (malls) School (approval from ministry of education ) Media and news papers
  • 32. + collecting sampling in our hospital )
  • 33. + Collecting Sample At PHC Collecting Sample In Our Hospital
  • 34. + Collecting sample at PHC Collecting sample in our hospital Dr. Sami Badawwod To start in 40 PHC in Jeddah King Abdulaziz university
  • 35. + HPV self sampling Collecting sample at PHC Collecting sampling in our hospital
  • 36. + ‫المركز‬‫السعودي‬‫للرعايه‬‫الصحيه‬‫المبنيه‬‫على‬‫البراهين‬ Guideline meeting for cervical cancer screening  Agreed among panel members that HPV testing will be used as primary screening for cervucal cancer in SA
  • 37. +
  • 39. + HR-HPV DNA in women 30 + years old Negative Negative Negative Pap test Positive Positive Colposcopy Positive Repeat HR-DNA testing @ 5 year intervals till age 65 Repeat HR- HPV testing at 12 months
  • 40. + 0 50 100 150 200 250 300 350 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 10 22 98 148 168 56 30 18 46 196 330 212 New Registration for Year 2012
  • 41. + 0 50 100 150 200 250 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 128 188 162 196 126 88 8 60 208 96 60 8 New Registration for Year 2013
  • 42. + 0 50 100 150 200 250 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 4 14 54 108 154 48 16 14 22 152 218 144 6 8 44 40 14 8 14 4 24 44 112 68 New Registration for Year 2012 – Saudi vs. Non-Saudi Saudi Non-Saudi
  • 43. + 0 20 40 60 80 100 120 140 160 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 98 124 80 156 78 64 2 16 86 66 36 8 30 63 82 40 44 24 6 44 122 30 24 0 New Registration for Year 2013 – Saudi vs. Non-Saudi Saudi Non-Saudi
  • 44. + In January 2014 will release our positive HPV data. Official opening of the program will be hosted by Dr. Khoshaim Mohmade.