FIRST DRAFT OF THE RETROSPECTIVE STUDY

Workshop MEDICELThe Mediterranean Network for Celiac Disease

III Progress MeetingPastaTrend, BolognaFiere

Bologna, April 5th 2011

RETROSPECTIVE STUDY • AIM: To evaluate the presence of the markers

required for the new ESPGHAN protocol in 50 unselected consecutive patients in each country

• 10 countries: Albania, Bosnia H, Croatia, France, Greece, Italy (Naples), Italy (Sicily), Morocco, Slovenia, Turkey

• ESPECTED RESULTS:• To estimate the percentage of patients who bear the

markers required by the new approach• To produce a quite original picture of the CD

diagnosis in the area

498 cases

DATA REQUIRED• Date of birth• Date of diagnosis• Sex• Biopsy results• Anti TGase (UI)• HLA genotype• 3 symptoms• Familiarity• Associated disease• Treatment

Statistics

498 460 177 128 133

0 38 321 370 365

Valid

Missing

NSEX BIOPSY HLA FAMIL ASSOC

F:M = 2:1

SEX

SEX

FemaleMale

Fre

qu

en

cy400

300

200

100

0

35,5%

64,5%

SEX

AGE AT DIAGNOSISAGE5

AGE5

3,002,001,00,00

Fre

qu

en

cy

300

200

100

0

46,5%

32%

16,6%

4,9%

0-4 y 5-9 y 10-14 y 15-22 y

AGE AT DIAGNOSIS/COUNTRY

COUNTRY

BOSNIA

SLOVENIA

SICILY

FRANCE

MOROCCO

ITALY

TURKEY

CROATIA

GREECE

Co

un

t60

50

40

30

20

10

0

AGE5

,00

1,00

2,00

3,00

0-4 y

5-9 y

10-14 y

15-22 y

HLA

HLA

NODQ2/8DQ2/8DQ8DQ2

Fre

qu

en

cy

160

140

120

100

80

60

40

20

0

74%

6,7%

16,3%

2,8%

Statistics

498 460 177 128 133

0 38 321 370 365

Valid

Missing

NSEX BIOPSY HLA FAMIL ASSOC

64,4% NOT Genotyped

FAMILIARITY

FAMIL

FAMIL

MORE THAN ONESIBDADMOM

Fre

qu

en

cy

40

30

20

10

0

28,2%

30,6%

17,7%

23,4%

Frequency Percent

%

Familiarity 128 25,7

NO Familiarity

370 74,3

ASSOCIATED DISEASESASSOC

ASSOC

OTHER

EPILEPSY

LIVER

DOWN

IDDM1

IGA DEF

DERM HERP

THYROID

Fre

qu

en

cy

70

60

50

40

30

20

10

0

11,4%

2,4%1,8%

4,8%

0,6%1,6%

0,4%

3,6%

73,3% No associated diseases

SYMPTOMS

ONLY 22 ASYMPTOMATICS

It is a SYMPTOMATIC CD

No differences betweenMales and Females

BIOPSY

BIOPSY

T3CT3BT3AT2T1T0

Fre

qu

en

cy

300

200

100

0

BIOPSY RESULTS

NOT DONE = 7,6%

3% 4,3%7%

14,3%

23,7%

45,7%

ANTI-TGASE LEVELS AND BIOPSY

132633616188N =

BIOPSY

T3CT3BT3AT2T1T0

TG

AS

E

250

200

150

100

50

0

148127

TGASEQUA

150,00100,0050,00

Co

un

t160

140

120

100

80

60

40

20

0

BIOGR

2,00

5,00

NO Atrophy

Atrophy

ANTI-TGASE LEVELS AND BIOPSY

<50 UI 50-100 UI >100 UI

LIMITATIONS

1. Selection bias

2. Bad management of the missing data: • Uncompleted files

3. Anti TGase: • Meaning of the NEGATIVE results• Lack of standardization

4. Biopsy: • Lack of standardization

LIMITATIONSCase Processing Summary

50 100,0% 0 ,0% 50 100,0%

50 100,0% 0 ,0% 50 100,0%

48 96,0% 2 4,0% 50 100,0%

63 100,0% 0 ,0% 63 100,0%

50 100,0% 0 ,0% 50 100,0%

49 98,0% 1 2,0% 50 100,0%

50 100,0% 0 ,0% 50 100,0%

50 100,0% 0 ,0% 50 100,0%

34 81,0% 8 19,0% 42 100,0%

16 37,2% 27 62,8% 43 100,0%

COUNTRYGREECE

CROATIA

TURKEY

ITALY

MOROCCO

FRANCE

SICILY

SLOVENIA

BOSNIA

Albania

BIOPSYN Percent N Percent N Percent

Valid Missing Total

Cases

FUTURE PROSPECTS

• Prospective study for 6 months (50 cases/country) to evaluate the applicability of the new ESPGHAN protocol

• A positive evaluation of the new protocol could reduce the confinement of the diagnosis to specialized centres only

THANK YOU