Document zzRVXZ9L4jgojv90XvVmgJYp0

5 -C tr I t fL I. n n . I Principal Investigators: Otto Wong, Sc.D. Applied Health Sciences, San Mateo, California, USA Tulane Universi New rieans, Louisiana, U Chinese Universi of Hong Kong, Hong Kong, China Fu Hua, M.B.! Ph.D. Fudan University School of Public Health, Shanghai, China 18 August 2004 Asilomar Conference Center, Monterey, California, USA SH ELL-MCCLU RG-063770 han hai ealth tudy _ The A L-NHL case-control study is one of the three research proje s of the Shanghai Health Study~ _ Clinical diagnosis is provided by the Joint Sino-US Clinical olecular Labora (under the dire ion of Dr~ Richard Irons)~ _ Exposure assessment is carried out by Fudanfs Exposure Assessment Team (under the dire ion of r~ homas Armstrong)~ SHELL-MCCLURG-063771 tudy si"gn Hospital-based case-control study in metropolitan Shanghai, hina~ o diseases under investigation: ~ cu myeloid leuke ia ( L), and ~ Non-Hodgkin Iy phoma (NHL)~ Prospe ive patient enroll ent starting in June 2003 Crepo ing in the first 2-3 months might have been sporadic and inca pie )~ SH ELL-MCCLU RG-063772 tudy si"gn e For each A L or NHL case, up to 2 individually matched controls~ e emographic, occupational, Ii Ie and medical in rmation obtained through the use of face-toface questionnaire interviews~ _ Individual exposure profiles for each study su "e s, with emphasis on benzene and other potential confounding exposures~ SH ELL-MCCLU RG-063773 tudy as e 29 participating hospitals in the study~ e Participating hospitals located throughout the ci ~ e Three pes of hospitals included in the study: unicipal hospitals! istrict hospitals, and ccupational hospitalsm SH ELL-MCCLU RG-063774 Partici atin spitals 1 2 3 4 5 6 7 8 SH ELL-MCCLU RG-06377S Partici atin spitals 9 10 11 12 13 14 15 16 SH ELL-MCCLU RG-063776 Pa ici ating spitals (2) istrict Hospitals 17 18 19 20 21 22 23 24 25 26 27 SH ELL-MCCLU RG-063777 Pa ici ating spitals (3) ccupational Hospitals 28 29 SH ELL-MCCLU RG-063778 SH ELL-MCCLU RG-063779 as s _ Acute myeloid leukemia (A L) and non-Hodgkin's lymphoma (NHL) patients aged 18 or older~ _ For NHL, both the broader H definition and the traditional ICD9 definition are used~ _ Preliminary diagnoses provided by participating hospitals~ _ Preliminary diagnoses to be confirmed by the Joint Sino-US Clinical Molecular Laboratory (JCML) at Fudan Universi ~ nly JCML-confirmed cases are included in the study~ SH ELL-MCCLU RG-063780 I .. II II th ntr Is e Same hospital as the cases e Same gender as the case~ e Similar in age (+ 5 years)~ _ Same inpatient/outpatient status (many NHL patients are outpatients)~ _ Lymphatic and hematopoietic diseases excludedB _ Closest admission time~ Note: Age can be relaxed + 10 yearsJ if suitable controls (+ 5 years) cannot be foundB SH ELL-MCCLU RG-063781 Id ntificati n f as sand ntr Is e Identification of cases and controls at each hospital is the responsibili of the clinical coordinators at the hospitaL e For AMl, the clinical coordinators are hematologists at the participating hospitals, under the supervision of Prof~ LIN Guowei of Huashan HospitaL e For NHL, the clinical coordinators are pathologists at the participating hospitals, under the supervision of Dr~ ZHU Xiongzeng of Tumor Hospi L SH ELL-MCCLU RG-063782 Int I"e f as 5 and ntr Is _ Newl diagnosed cases and rna hed controls are ident ed by clinical coordinators at each participating hospi Is~ uestionnaire interviewers at Fudan are notified of new cases and controls. _ Face-to-face interviews at the hospital (by the bedside) are to take place within one week~ e Interviews are condu ed by trained questionnaire takers! under the supervision of Dr~ Chen Xiaobao~ SH ELL-MCCLU RG-063783 Int I" f as s an ntr Is Each patient receives: _ A verbal description of the investigation, _ Disclosure of the identities of sponsors and investigators of the study~ _ Reassurance of voluntary participation, _ Reassurance of the release of statistical data only, and _ Reassurance of confidentiali of personal information~ SH ELL-MCCLU RG-063784 Int I" f as s an ntr Is If the patient agrees to participate, he or she is asked to sign the appropriate consent forms~ Each patient will receive financial compensation of 240 R B (240 yuans, or approximately U5$30) for the interview~ A 17-page (prima ) questionnaire in Chinese is then administered verbally by the interviewers (average: 30 to 45 minutes per interview)~ SH ELL-MCCLU RG-063785 ri"ma uesti nnair The 17-page prima questionnaire contains the lIowing sections: e Demographics, e Family histo f e edical histo f e edication history (both estern & Chinese traditional)! e Employment and exposure histories! and e Non-occupational exposures (tobacco, alcohol, hobbies rming)m SH ELL-MCCLU RG-063786 ec nda u sti nnair s _ Certain occupations of interest will trigger secondary questionnaires that are more detailed and industryor occupation-specific (ranging from 4 to 9 pages)s e 64 occupations of interests have been identifieds Examples: shoe worker, leather worker, painter, mechanic, farmer, mechanic, mechanist, ele rician, assembly worker, health care worker, te ile worker, laborer, manager supervi.sorm SH ELL-MCCLU RG-063787 ec nda u sti nnair s pical seconda questionnaire contains the 110 ing information: Indust and occupational title, escription of tasks, Substances handled, Frequency and duration of exposure, orkplace environment, and Use of personal prote ion equipment~ SH ELL-MCCLU RG-063788 uesti nnair 5 Before data entry, each questionnaire is checked for completeness and clari by Dr~ Chen~ Verified questionnaires are then copied and stored in locked file cabinets in a separate building~ Copies of questionnaires are sent to the data entry team~ SH ELL-MCCLU RG-063789 uesti nnair 5 uestionnaire data ent : ouble data entry by 0 independent data entry personsl Results compared, and iscrepancies revie ed and resolved by data ent supe isor~ SH ELL-MCCLU RG-063790 Exp su r ssessm nt erified questionnaires are processed for exposure assessmentm nly the employment and exposure sections of the questionnaire a provided to the Exposure ssessment ea (blinded as to case/control status)~ SHELL-MCCLURG-063791 Exp sur ssessm nt Exposure classification of study subjects is assigned by the Exposure Assessment Commi ee (blinded as to case/control status)~ The Exposure Assessment Commi ee consists of: e Dr~ YANG Shixin, a retired occupational physician from IPHS who is familiar with many ories in Shanghai, e Professor JIN Xipeng at Fudan Universi who has published extensively on benzene, and e r~ HE Yonghua, Exposure Assessment Coordinator~ SH ELL-MCCLU RG-063792 Ex sur ssessm nt Primary sources of exposure information: e Shanghai unicipal Institu of Public Health Supervision (IPHS) database (co puterized), " Exposure data at distri IPHS (not computerized)~ _ onitoring data maintained at factories, e Facili hi ories (raw materials, engineering changes) main ined at Dries, " New a hoc monitoring data to be colle ed, and " Exposure information in Chinese journalsm SH ELL-MCCLU RG-063793 Exp su r 55 ssm nt Source Data potentially available SH ELL-MCCLU RG-063794 Exp sure ss ssment IPHS database: _ a dated back to the 1950s, _ Some 50,000+ exposure measurements of benzene taken at fa aries in Shanghai, _ ccupatianal codes and industrial codes have been standardized to the classifications used in the 1982 national census, and _ Records in computerized form (FoxPra)~ SH ELL-MCCLU RG-063795 Exp sur ss ssment SH ELL-MCCLU RG-063796 Exp sur ssessm nt IPHS exposure records include the following items: e ate of sampling, " Industrial code, e ccupational code, " Hazard code (0715 for benzene)! e Name and address code of the factorYI " Sampling location at the facto I and e Individual and average measurements of benzenem SH ELL-MCCLU RG-063797 I H Ex sur c rds Date Industry code Occupational code Hazard code Name & address code of factory Sampling location Measurements (mgjm3) SH ELL-MCCLU RG-063798 IPH Exp sure c r s X:~~:: ~I~ W~~~"'.F'/'.F''.F'/'..A6 /'0b);-A#~1(7!':'F'A".A r~H~ ?~ #A"~l ~ff...l ~ ~F../fi ? I ' I'/h~ I f, r.~~ ~~hM:/--~**~~ h~~~~....j. ~~~~~'..Q..........~b-f.i: r~~~.F. ..F. ...M: {~u"/......~.AJ... ::ir~.'...".~.~j; :~:: .-~ J\B~ Date Industry code Occupational code Hazard code Name & address code of factory Sampling location Measurements (mg/m3) SH ELL-MCCLU RG-063799 p rts in hines e leal J urnals enerally, 0 pes of articles in hinese medical journals repo ing benzene exposure information: Industrial hygiene surveys, and Benzene poisoning cases. SH ELL-MCCLU RG-063800 p 5 in hines e ical J urnals "Control of benzene exposure and health effe s at Jinan Steel & Iron Company's Coal Tar Plant" _ in J 1999;12(3):179~ e Authors: ang LC, ei YZ, Lin ZX~ _ A liation: Jinan Steel & Iron Company~ e Text in Chinese~ SHELL-MCCLURG-063801 e s in hin 5 dical J urnals _ Benzene refining unit at Jinan Steel Iron Company's Coal Tar Plant (iJf1J~~1V~0Pjm1tr)~ e Comparison of benzene measurements by work area and year~ e ajor renovations (primarily ventilation) since 1980~ SH ELL-MCCLU RG-063802 R P 5 I. n hin s dical J urnals Benzene measurements (mg/m3) at refining unit ork area Distillation ashing -r' Finished produ !~IW:1I Chemical analysis ft#NI SH ELL-MCCLU RG-063803 p s in hines e leal J urnals "Analysis on the benzene poisoning event about aobeidian's bag industry in 2002" (authors' translated title) _ in 2003;30(3):32-34~ e Authors: Zhao ex, Luo R, Li J ~ _ A liation: Hebei Provincial Center for Disease Prevention and Control ~ _ Text in Chinese, with an English abstra ~ SH ELL-MCCLU RG-063804 p s in hines e ieal J urnals _ Health survey of leather bag processing workers in 2001-2002 in aobeidian Ci f Hebei (1TIJ~~ -~:rr~m-m)~ _ 6482 workers (4906 females 1576 males)~ _ 33 cases of benzene poisoning (including 31 serious cases: 23 f 5 pan openia, 2 5 1 A L); prevalence rate=0~51 Om _ 9 deaths; fatali rate=17~6%~ _ 27 females 6 males~ _ Age: 16-22, average=17~ SH ELL-MCCLU RG-063805 p s in hines e ieal J urnals e orkshops were converted rooms in residential houses; 30-80 m2; inadequate or no ventilation~ e f the 20+ adhesives used, 7 with benzene content >30 0 ~ e Employees worked, ate and slept there~ e 12-17 working hours a day; no days 0 s e Benzene concentrations up to 2040 mg/m3~ e Toluene up to 949 mg/m3~ en-hexane up to 85800 mg/m3~ SH ELL-MCCLU RG-063806 Typical ak shi rksh ps A young woman applying glue from an open conta iner to a smail hand bag with a brush. Note the location of the exhaust vent SH ELL-MCCLU RG-063807 hines edical Literature Sources: Shanghai unicipal Libra (all years available), Fudan Universi edical School (2000present), hinese Scientific edical Journal Indices (1980-present) rp ~ ~~f~:;iZJtR fiJ ~)ttJ Wm SH ELL-MCCLU RG-063808 hines edical Literature Key words used in identi ing potential journals, conference proceedings, books, & agency reports: e Public health, e ccupational health/medicine, e Preventive medicine, e Industrial health/medicine, e ccupational diseases, and e ccupational poisoning8 43 journals plus 40 other documents SH ELL-MCCLU RG-063809 hines edical Literature he title and/or the abstra of every article of the selec d journals or report is searched for the 110 ing key ords: benzene, gasoline, glue, and painte If one or more key ords are found, the entire article is copied at the library and brought back our 0 IceSe SHELL-MCCLURG-063810 hines edical Literature The copied articles are then read and the lIowing items are entered into an Excel spreadsheet: e Industry! e ccupational title! e Task description, e Date, e Benzene exposure levels! e Description of physical environment, and e Diagnosis8 SHELL-MCCLURG-063811 hines edical Literature he Excel spreadsheet contains: II post-1980 articles or reports, Nearly 1000 line ite Sf and Each line contains one set of benzene easurement (representing a sa piing location or job title, ith one to several benzene measurements)~ SH ELL-MCCLU RG-063812 tudy tatus ummary Enrollment of patients started in June ( L) or August/September eN L) 2003~ he delay as due to the late completion of J Land S RS in 2003e Patient en IIment in the first 2-3 months ight have been sporadic and incomplete at so e hospitals~ SHELL-MCCLURG-063813 tudy tatus ummary Number of JC L-confirmed cases proje ed for the 12 months ending on 4 September 2004 and by end of 2006: Diagnostic category Original estimate 12 months Current projection 12 months Expected cumulative by Dec. 2006 SH ELL-MCCLU RG-063814 tudy tatus ummary So far, no cases or controls refused to participate in the study~ e have been able to sele t 0 controls for eve case~ SHELL-MCCLURG-063815 tudy tatus ummary In February 2004, a review of the questionnaires of cases and controls revealed: uite a few outpatient NHL controls at Tumor Hospital lived at the same address or in the same neighborhood (n=21, 51 % of all controls at Tumor Hospital), and Several outpatient NHL controls at No~ 6 Hospital were health care workers, Le~, nurses or physicians (n=6, 50% of all controls at No~ 6 Hospital)~ SH ELL-MCCLU RG-063816 tudy tatus ummary Further investigation revealed: These "recruited" controls were relatives, neighbors or coworkers of the clinical coordinators at the 0 hospitals~ These controls were not "real" patients at the hospitals, and their diagnoses were non-specific, such as upset stomach or minor respirato symptoms~ These controls registered at the hospi Is as outpatients (registration fee of 10) so that they could participate in the study and receive study participation fee of 240~ SH ELL-MCCLU RG-063817 tudy tatus ummary Corrective and preventive measures implemented: Talked to the clinical coordinators involved~ As of ay 2004, require all controls be sele ed from inpatients, regardless of the status of the caseS8 Replaced the inappropriate controlss Closely monitor the sele ion of controls8 Review distribution of controls by diagnosis, address, or occupation~ SHELL-MCCLURG-063818 tudy tatus umma Total number of completed questionnaires Number of que ionnaires entered Number of questionnaires verified Number of subjects assessed for exposure SHELL-MCCLURG-063819 tudy tatus u ary ost frequent occupations/industries of benzeneexposed subjects: Shoe workers, Painters, echanics or mechanists, and Printers~ SH ELL-MCCLU RG-063820 tudy tatus ummary Earliest exposure ccupation with highest exposure Highest maximum exposure Highest minimum exposure Highest pical exposure Longest exposure SHELL-MCCLURG-063821 tudy tatus u ary ost equent occupations/industries of subjects exposed to other substances: Farmers, e ile workers, Teachers, Engineers, ri.vers, Cooks, chefs, ilita personneL SH ELL-MCCLU RG-063822 tudy tatus ummary The Exposure Assessment Team noted the following: Completeness and accuracy of the Shanghai unicipal IPHS database Crepo ed by local/distri IPHS)~ Timely access to IPHS database~ Scheduling factory visits through IPHS~ Limited usefulness of data from the literature~ SH ELL-MCCLU RG-063823