Document 3eM8EGpZ6GONNN3oey3p5md4y
Background
j)hanghai Health Study Overview
ExxonMobil Use Only
a.~
~ Funders:
Technical Collaborators:
Five-year clinical epidemiology
XOM BP
~ Chevron
~ ConocoPhllllps
-
study to Investigate causes and
!"l) <.. l
.. 0.
development of Iympho-
hematopoietic diseases as
rei ted t
s;I
t/J
Shell Chemical
-oooI
\0
EMBSI Role:
---1
Fudan University Unlv. of Colorado Applied Health Sciences, Inc: Shanghai Public Health Agencies Shanghai Hospitals
Subcontract with University of Colorado
Exposure Sciences: Tom Armstrong - Sr. Scientific Associate
Vlmel Zhou - Scientific Associate
Epidemiology:
Rob Schnatter - Sr. Scientific Advisor
Data Systems I QA: Gail Jorgensen - Information Technology Associate
Shanghai Health study Update - Health Network Meeting - Decembet 5, 2005
3
Background
.Benzene Health Research Consortium
Organization
With ExxonMobil Representatives
Oversight Committee
Brian Doll - Vice Chair
ExxonMobii Use Only
Technical
Michael Bird Steve Bowes - Budget
Communication
Lynn Russo - Chair
Recruitment
.Myron Harrison
Legal
Glenna Kyle
API Administrative Support.
ai1ghai Health study Update - Heallh Network Meeting - December 5, 2005
4
Background
SHS Structure
r
Clinical Laboratory Support
28
/
ExxonMobil Use Only
I
: Outside Referral
I Benzene Cases
./'onSUltation
r-------~----------~
Exposure
4 :S~MCi}:~p-.i .iP.H.S
Case
(~harigi1~'~3'gO:y~rninel1~al
1.0. .. '.~ . ,ag~.fI~~e.$) . .
#~. , , ; ,
. . .. . '
S anghal Health study Update - Health Network Meeting - December 5, 2005
5
..~--.~---.---~.--- --.---~--------.----------
Background
Objectives of 3 Studies
ExxonMobil Use Only
Case Control (CC): Determine -risk of developing AML or NHL
among workers exposed to benzene.
Disease Progression (DP): Characterize disease precursors
and potential unique clinical features of benzene induced disease, including AA, MDS, AML, benzene poisoning.
Molecular Epidemiology (ME): Identify exposure and
susceptibility biomarkers for benzene exposure.
o(~.('t~)
0-
n~
("""I--
S~anghai HeaUIt Sfudv Updale - Healflt Network Meefio9 - tlecetrlbet 5, 2005
6
--
I
o sr:;:.,:-.
<I ~
.Elanned VerS.U5 'Current P~ogress
Planned
)
:.xxonMobll Use Only
8/01 1/02 1/03 1/04 1/05
1/06 1/07 6/07
_ _ _ _ _ _l1liI._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _..-.1I............J
Current
Start-up met unanticipated challenges (e.g., SARS) Patient recruitment phase slightly compressed due to more hospitals cooperating Report and publications appearing earlier and ending later
I I Laboratory Start-Up, Design, Staff Recruitment, Training, and Pilot Studies iii Patient Recruitment, Data Collection, Data Entry, Translation, Exposure Assessment, and QAlQC
Statistical AnalysiS, Report and Publications
S~anghai Health study Update - Health Network Meeting - becember 5, 2005
7
o'-+-:;:0 0 0..0..
~
n
ExxonMobll Use Only
Recruitment to Case Control and DP Studies
JCML Patient Diagnosis
120
100
>::t::
,N 1/1
t.f.I
::t::
Cii
0
> 80C
I
0 0
Ol
(U
00
-'D.:.
'" 60
40 +---~--~~-r------------------------------------~
20 or~
~'S3-
(;> ~ ."o
&>
0,).
~
<:.t ~$'
<:.t ~.;.
<:.t
~,:t.
.,..<:.t
~.:>
:;.~
~o
Month /Year
Sh~trghai Health study Update - Health Nelwotk Meetll1/1 - becem~r 5, 2005
~ '),f
~ ..<::> .
~'f
~
~,:t.
~
'S3-
<h:.I
."q,Q,
8
Planned versus Actual Prosress
Planned
~~
(0 (0
0... 0... ~
ExxonMobll Use Only
8/01 1/02
1/03
1/04 1/05
1/06 1/07 6/07
_ _ _ _ _ _..._ _ _ _. ._ _ _ _ _ _ _ _. ._ _ _ _..'..............1
Cu rrent
3rd SHS
Start-up met unanticipated challenges (e.g., SARS) "'A-_nn_ua_l M_ee_tin-g---'
Patient recruitment phase slightly compressed due to more hospitals cooperating Report and public~tions appearing earlier and ending later
laboratory Start-Up, Design, Staff Recruitment, Training, and Pilot Studies
~ Patient Recruitment, Data Collection, Data Enlry. Translation, Exposure Assessment; and QA/QC
. Statistical Analysis, Report and Publications
, S~anghai Health Study Update - Health Network Meeting - Decem er 5,2005
ExxonMODIi use umy
( -- . ' .
./
Third SHS Annual Meeting - November ~-3, 2005
/
Technical Highlights
0tl<.,.!,:.d
~
/ Chronic exposure to high benzene (e.g., >13 ppm) results in a unique
form of dysplasia
- "Benzene Induced Dysplasia" - BID
~ - Paper published
N
I
t;/.l
- TSCA 8(e) filed by EM
~
oooI
\Q -.....l
- Indicates benzene may have a unique signature Use of new WHO classification of tumors is significant
00 Nutritional anemias identified as confounders
- 200/0 (63/303)of cases triaged as AA, MDS, or Leukemia
confirmed to be nutritional anemias
- Possible follaw-uD activitv far Fudan
n r oo...~ ~f;/
(to-
Shanghai Hcallh S.tJdV Updalc - Heallh Nelwotk MeeliriU -Oeca ber 5.2005
10
~ """""m.-'ruLe My"J1Gd 1e\111.~., (MILl
AOJiII~B
"""....bIa ....
,,=~eM'110
8c.tIl !1mttl'lo1llntar..
AculI! 1::1- 'r~lItf'lt lNk.m... !ALLV
e.-.ee1)1ymptoCI!bIaNr1; ry~
N (Al.LI I
Ul
s:I
ooo C:"rorac e'lympl'lae-(ic
Q.OOI,,", &-fr11'4lh~bC JNfo.tmtI (BeLl)
\0 III~Wf""
8-co1 tI'.".1 twn~"c 11"'I'''om8
"'4 ta-Cltl
\0
Leukemias
proposed WHO classlf,cabol1- c:hVlSlon according \0 cell lineage
ExxonMobii Use Only
SHS Annual Meeting - November 2-3, 2005
. .1_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Process Highlights
Project on schedule and budget -
Laboratory will be sustained.
~
N
- JCML moved to Fudan University School of Medicine
I
til
~ - Richard Irons apPointed professor at Fudan
>ooo
\0
o00
7 SHS Papers published or submitted
Timeline to 2008 developed jointly by Sponsors & PI's
SRP and ERP members involved and committed
Sbanghai ~eallh study Update - Health Network Meeli\1U - beteh'lbet 5, 2005
. 11
t86000-VHS-ZVH
p:tJ:Jt?P:tH
I
>m<
.,(")
(I)
"..,C..,......
0
3
c
-"""I:
!I
"""I:
0
..:::J
fA
C
"tJ
.-,c
(I)
tn
C'D
P~l'J
-eP-alI
::l
-srru++.
:0:s
m
)(
)o(
::I
iog:;
c
~
o -<::I
_c._. ___:._.,
._ _._ _ _ _ . _._.__..!...!o:.: . ..:..:"'-'U .........,.,U ...~U---'-L-___ ''' ..... ~~.___ . __._.~ .. _ _ _ _ .~_.__.__ . __ .
ExxonMobii Use Only
CC I DP Exposure Assessment Progress
1111 Case rec~~it~ent!ll Data ~ntry 0 Preliminary EA- Final EPi
4
"0 <U
->::c-:
~ C.
N
EI
>:t::cI:l
0
(,)
aaaI
en <eUn
-0 00 N
ctI
(,)
-0
~
As of 11/04
As of 9105
Target
Note: As of Sept. 30, 2005, a total of 3981
/.
cases recruited, about 14% ahead of planned
recruitment
Shanghai 'Health Study Updale - Health Network Meeting - Oetember 5, 2005
: 1'3
- -.
' ..".-
-'-.' -."-'-'- ._._. . . -
"---..
---
-
_':'-"'c_. --.:-..:.... _~.::~.'.:,.~:.:..::J::..l:.:~~'-'~=-;..]..;l........:..:'-"~.. :..:..~~.i..:. _:....,,~"'~...---,-_..,.,~---,- .... ___ .. _'. __ .
CC I DP: Benzene Exposed Subjects
ExxonMobii Use Only
Q..~::t1
o.-+ O. Q..
~ Painting
o Others
Shoe making
~ Rubber,
1II Home renovation; -..
o Mechnical repair o Printing
o 70/0
1!!11170/0 C!tl Ie
- Preliminary exposure assessment identified a total of 259 subjects (out of 3766) as "Benzene exposed".
.'
I
Sl)anghai Heallh study Update - Health Network Meetirl!J - Oecember 5, 2005
14
- ' .Case Control Studies Tiered Design: . Expectation of Fewer Subjects Completed at Hi
Robust database, site visits, task data,
retro EA skills
ExxonMobil Use Only
Quantitative & Pattern of
Ex osure
~.
N I
rIl
~
oooI
\0 00 .f:>
/'
,.
.. "
S anghai Health Study Update - Health Network Meeting - Decembef 5, 2005
, .'
15
ExxonMobil Use Only
Case Control Studies Tie"red Design:-~_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ......... t''::':,,~.~''~
Expectation of Fewer Subjects Completed at Higher Tiers
Robust database, site visits, task data,
retro EA skills
Quantitative & Pattern of Ex osure
~
N I
til ~
;J;> ooo
'"00
VI
(BED I SEL) Shanghai Health Study Update Health Network MeeUng, June 27, 2005
11
!rogress: ME Studies
ExxonMobii Use Only
p.~
~
s~:;.::. ;t(:"I)I
,,,",, ,- . -r' .
.- .
Phase I (Past benzene exposure and clinical blood values)
>- Goal: 2000 workers
);>' Status: 1500+ workers across 19 factories
);> EA completed for 17 of 19 factories
);> On schedule - will be completed in 2006
Phase II (Recent/current exposure and clinical values/biomarkers)
~ Goal: 1000 workers
);> Status: 233 workers from 3 factories
}> EA completed for atl three factories
);> Participation affected by we$tern-oriented recruitment
strategi e s "
. 'a. u g. W
);> Minor changes to worker consent documentation endorsed by Ethics Review Panel
.. Sha~ghai Health Study Update - Health Network Meeting - Dece ber 5, 2005 ' .
.
. ' .' 16
