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t r i 1 Form ap pro.« OMB No. 0925•000' .e ~ LEAVE BLANK DEPARTMENT OF HEALTH ANO wulAsu ceevtr•ee ' ,~ PUBLICMEALTH SE.„ MAME' COf;FEA,, FELr1Y0i ARPL N0: 1 RO1 CA40095-01 COUN DATE : 05/85 - GRANT APPLIC, DATE RECD: 1'0/12/84 ~iOLLOw INSTRUCTIONS - Z kG : SSS - 1. TITLEOff ARPLICATION'.fDonoteuoa.d5Etype...it.raPaosl Lung t_-ant*Pr in non-cmokinQ wnmPn FIC PROGRAM ANNOUNCEMENT. 0 NOg1iYES bL"YES,"mte.RFAnunrDranQ/oranrravnanwn[tiiNl Involuntary exposure to tobacco smoke and cancer risk 3+~HI18~E_(Laft {irst. nriddAel. CORREA, Pelayo 9..PERFORMANCESITES/Organwrionsandaddressae/ -Louisiana State Univ. Medical Center 190 1 Perdido-New Orleans LA 70112 Center Atl anta GA -Resource ~ for Cancer Epidemiology, CA* -Atlanta Ca CeD Surveillance Calif. Tumor Registry,Emeryville Dept Calif., ~A -Univ. of Texas Health Science - of Family Medicine,Univ. of So ., Los Angeles CA* Center at Houston, TX* *CONSORT2UN4 3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR 3b. SOCIAL SECURITY NUMBER 30. POSITtONTITLE 3d. MAILINGADDRESS/Sn.aLaty,stan,.ripcpoll Professor of Pathology Department of Pathology Louisiana State University 3e• DEPARTMlNT,SERVtCE, LABORATORY OR E UIVALENT Medical Center 1901 Perdido St. Pat logy New Orleans LA 701112 3(. MAJOR SU IVISION 39. TELEPHONE /Aeea coOS. numDarand ixtensionl. School of Medicine (504)568-6035 4:, HUMAN SUBJECTS 5. RECOMBINANT DNA ' nemption M 0 E [) NO ~ YES. SOR $) NO C) YES 111 21 Form HHS 596 encloeed B. DATES OF ENTIRE PROPOSED'PROJECT PERIOD 7. DIRECTi COSTS REQUESTED B: DIRECT COSTS REQUESTED' FOR FIRST 12-MONTH BUD- FOR ENTIRE PROPOSED GETPERIOD(Irornpay.A PROJECTPERIOD(IroropagsS'~ From: 1-1-86 Tr'ra+~': 12-31-88 5439,333 s 1,31-5,174 10. INVENTIONS7Cwrwerin conrinwtionapWiuriononlel' a P r„"°"sy `°°rt.d i 0 NO 0 YES ~IOR t O Nnt pnnourlp eporred 11~ APPLICANTORGANIZF:TION(Narrw,addnst,anW COn9nraiona/ Louisiana State University Medical ' Center I1440 Canal Street ew Orleans, LA 70112 12: TYPE Of ORGANIZATION 13-. ENTITY IDENTIFICATION UMBER A~ 0 Public. Specity, Q F.daal astateO Lowh 1-72600084S 0 Privete Nonprofit 0 FocProfit lGa dl I14., ORGANIZATIONAL COMPONENT TO RECEIV E CREDIT FOR nr C3 ForProfit (Small auaineal BIOMEDICAL RESEARCH SUPPORT GRANT Code v~T~ ~ i y Descriot;on 15- OFFiCIAL.IN.BUSINESSOFFICE TO BE NOTIFIED IF AN AWARD 18:.OFFICIAL S)GNINGFOR APPLICANTiORGANIZATION IS MADE (Name. tith, addirra and rolepnonenumGr.) fNama, tirlb.eddnsr and ro/sphone rmrmAerl. Mr. Robert Bourgeois, Director Dr. John R. Walker, Assistant Vice- Aecounting Services, LSU Medical! Center President for Academic Affairs 1440 Canal Street, Suite 1510 LSU - 115 System Building New Orleans, LA 701112 Baton Rouge, Louisiana 70803 (504) 568-4812 (504) 388-21i11 17. PRINCIPAL INVESTfGATOR/PROGRAM DIRECTOR ASSURANCE: . eet I agree to accept re.pomitli/ity for en. +nenuHC conduct of the proi eet and to provide the requinsd progtau reports,t a gramt,+ awarded a. a re. SIGNATURE OF PERSON.NAMED IN 38 .lln ink. " ' seqn ure n~ar~e.OraoN/~ ~ DATE Iult Of this appHution. 1Killlul prowston of'tat/p information if a uimmal'. ~ , [[[ t•• MMM ••• •••ttt otfans. (p:S. Cod.. Ttre 18, S.etion t0011: }}} ~ 18. CERTIFICAT~tONANDACCEPTANCE: Ik.rtr,ry,Matn.+utemenvrn.~ In a1~ tnla Md la n a d f N NAMED IN 18 .$1GNATURE OF P E R S O QnarunnoraCCfOrap/el Per" n ,(!n N DATE Comp . O t. to the best o my, knOwl.dge, en OCGAt t liqaiort.to complywitn Pubtic.HS.IthS.rvce tarms and conditiom d a. ~ / ~ ~ /~ ~ ' - Rant iraywrdads rM rsfult'.of tni+ appfiuUOn, A wdlfully re1N cemli- 11 . . . / W-~ V cation i. a cnmmaf. offsn+../U.S.Cade. TitN tB,.Secrian 100t) . PHS 398 (Rey: 5/82) t<

PRINCIPAL INVESTIGATUtirrROGRAM DIRECTOR.: Pela'•.JTrea, M. D. ABSTRACT OF RESEARCH PLAN r E KEY. PROFESSIONAL PERSONNEL ENGAGEl PROJECT NAME POSITION` TITLE Pelayo Correa,M.D. Professor Elizabeth Fontham,DrP Assistant Professor Vivi'en Chenl, PhD Assistant Professor DEPARTMENT AND ORGANt2ATIOR LSUMC-Dept. of Patholoc LSUMC-Dept. of Patholoe LSUMC-Dept. of Patholoc Raymond Greenburg,MD, D Asst.Prof. & Director Div. of Cancer Surveili~ David Simon, M.D. Assistant Prof. of Medici e Emory Univ. School Me Donald Austin, M.D. Chief,Resource for Cancer pid. Calif. State Dept. of Health Services w w  w Anna Wu, PhD Assistant Professor Dept. of Prev.Med.U.S.C Duncan Thomas, PhD Associate Professor lUSC)', School of Medicine Patricia Buffler, PhD Asso. Dean & Proiessdr Univ.of Texas Health ,Science Center-School c IPubLic Health Peggy Reynolds, PhD Epidemiologist Vonnie Gurgin, D.Crim. Asst. Chief, R.C.E. ABSTRACT OF RESEARCH PLAN! . Stare the ,wpl-cadion's.long.term objecrives and snecrfic arms, makmg reference to the health rdavedness or'^ prolect, and des[ribe.t:nnc,sely rhe methodology InrI aehrevmg thesee goals:. Avordd sl/mmanes p1ip2st ac[Omplishmemts and. Ihe ule of the first pi•.~' The abstract -s me3nriro seVSVr es asucui-I Jnd ,N:cUr;IIU desl`l of theproOosCd work.wfren SeOarated from the aQpheatWn. DO NOT EXCEED. THE SPACEPROVIDED. This study attempts to test the hypothesis that involuntary expo- sure to tobacco smoke increases the risk of lung cancer. It is a population-based case-referent (controll) study of women who never used tobacco products and develop lung cancer. Cases will be rapidly ascertained in five large metropolitan areas: New Orleans, Atlanta, San Francisco, Los Angeles, and Houston. There will be two separate control groups: non-smoking women who develop colonlcancer residing in the same geographic area as the cases; and a population control group obtained by a randomldigit dialing protocol. Personal interviews at home will be conducted. The questionnaire will cover passive smoking exposures at home, at work, and in other areas; residential character- istics; diet; and demographic information. Logistic regression techniques willl be used in the analysis to examine risk of lung cancer associated with passive smoking while controlling for confounding variables. The data processing will be centralilzed in one of the participating centers, Atlanta, and the analysis will be a cooperative effort of the investigators. VERTEBRATE ANIMAL6 INVOLVE-0IXNO F i YESII "YES," acnr4hv bvcommon nomcs snn ondernne pnmates.. PHS 398 IRev. 5/821 ~ PAGE 2

19 t PRINCIPAL INVESTIGATORlPROGRAM OIREi:TORc Pelayo COrrea. r'1.13'. TABLE OF CONTENTS H Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 54, 5b. Type the name of th Principal Investigator/Program Director at the top of each printed page and each continuation page. SECTION 1. PAGE NUMBER 1' 3 Face Page, Abstract, Table of Contents .................... Detailed Budget for First 12 Month Budget Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Budget for Entire Proposed'Project Period! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Budgets Pertaining to Consortium/Contractual Arrangements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18 Biographical Sketch-Principal Investigator/Program Director (Not to exceed two pages) . . . . . . . . . . . . . . . 19 Other Biographical Sketches (Not to exceed two pages for each) .(T4o Pr . 34) . . 21-40 Other Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (nq .P.•. 462 ............. . . . . . . 41-50 Resources and Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 SECTION' 2. Research Plan Introduction (Excess pages; revised applications,• supplemental applications) . . . . . . . . . . . A. Specific Aims (Not to exceed one page) ............................ B. Significance (Not to exceed three pages)' ............................ C. Progress Report/Preliminary Studies (Not to exceed eight pages) . . . . . . . . . . . . . . 0. Experimental Design and Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E. Human Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F. Vertebrate Animals . . . . . . . . . . . . . . . . . . . . . • . . • . . . . . . . . . . • - • . . G. Consultants . . . . .. . . . . . . . . . . .. . . .. . .. . . .. . .. .. . . . .. .. .. . H. Consortium Arrangements ...................... I. Literature Cited ........................................... Checklist .................................... SECTION 3. Appendix (Six sets) (No page numbering necessary for Appendix) Number of publications: Number of manuscripts: Other items (lisd:' Abstract Interview Schedule Consent Forms and Letters to Physicians Letters of Proposed Consortium Agreements 2; Application Receipt Record', Form PHS 3830 ® Form HHS 596 if Item 4, page 1, is checked "YES" and'no exemptions are designated. PHS 398 /Rev. 5/821. PAGE 3

0 I GR'tNfPe , 4-C LS Lc. PRINCIPAL INVESTIGATC: -+.uGRAM DIRECTOR: Pelayo Correa, M.D. DETAILED BUDGET FOR FIRST 12 MONTH BUDGET PERIOD O TS ONLY CT FROM 1-1-86 THROUGH 12-31-88 DIRE C S DOLLAR AMOUNT REQUESTED (Omit cenr. PERSONNEL lApplicant organization only) TIME IEFFORT NAME POSITION TITLE y~ Hours per Week SALARY FRINGE TOTALS BENEFITS orrea M.D. PrincipalInvestigator 10 4 Elizabeth Fontham DrPH Co-Investi ator 10 4 0 4 - esea ch Associate 100 40 ti ea ch Associate 100 40 jill r1grk ecretary 20 8 r SUBTOTALB $53 79 CONSULTANT COSTS None " EQUIPMENT (Itemize) None SUPPLIES (ltemize by category) . Consummable supplies, $120/month $1440 ~I 1~ -' "r Fl531 .:°a T1~A-N S"7(~- ~ 2~ PCL T's O0eA, `e X~ot . , ¢4 c -4^; 4~r&- EL T DOMESTIC Trainin session, abstracting, interviewing , RAV FOREIGN P TIENT CARE CO T INPATIENT A S S OUTPATIENT ALTERATIONS AND RENOVATIONS Iltemize by category) None f~Q4159a0 CONSORT I UM/CONTRACTUAL COSTS Atlanta Cancer Surveillance Center, $82,835 University of Texas Health Science Center at Houston, $87,931 University of Southern California, $101,144 R.C.E./Northern California Cancer Program, $92,885 OTHER EXPENSES (Itemize by category) ' Photocopying $50/month $ 600 Printing (questionnaires, abstracts, forzns, etc.) $5000 Cotinine tests and slide preparation $5300 ShippinR of specimens $ 800 TOTAL DIRECT COSTS (A/so enter on page 1, item 7) - $364,795 TcLeI, heNe 11200 Sec~n1,~H 13/-1°0 fLLpeTIOIh( -1„'~ 8 r o S 439,333 PHS 398 /Rsv: 5/821 PAGE 4

PRINCIPAL INVESTIGATOR/PROGRAM DIRECTaR: Pe ZaVO Correa. M. D. BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD DIRECT COSTS ONLY 0 BUDGET CATEGORY 1st BUDGET ADDITIONAL YEARS SUPPORT REQUESTED TOTALS PERIOD (from psgr 41 2nd 3rd 4th 5th P£RSONNEL (Saleiy and lringe henelitY.1 (AVOlic.nt ory.ni:arion only) 53,798 59,179 63,614 CONSULTANT COSTS EQUIPMENT SUPPLI E5 3,440 2,772 2,911 DOMESTIC 5,600 2,726 2,250 TRAVEL FOREIGN PATIENT INPATIENT CARE , COSTS OUTPATIENT ALTERATIONS AND RENOVATIONS CONSORTIUM/ CONTRACTUALCOSrS 364,795 380,024 373,065 OTHER EXPENSES 11, 70:0 6,700 7,600 TOTAL DIRECT COSTS 434,333 451,401 449,440 TOTAL FO R ENTIRE PROPOSED PROJECT PERIOD (Also enter on page 1, item 8) S 1,33 ,174 JUSTIFICATION (Use continustion pages if necessary): Describe the specific functions of the personnel and consuitants. If a recurring annual increase ~ in personneFcosts is anticipated, give ths percentage. For sll yesn, justify any costs for which the need may not be obvious, such as equipment. foreign travel, alterations and renovations, and consonium/contractual costs. For any additional years of support requested, justify any significant increases n any category'over the first 12 month budget period. In addition, for COMPETING CONTINUATION applications, justify any significant increases over the current level'of support. PHS 398 (Rev. 5/82) PAGE 5

Pelayo Correa, M.D. Budget Justification Personnel Principal Investigator - No funds are requested for Pelayo Correa, M.D., Principal Investigator. Co-Principal Investigators - Drs. Elizabeth Fontham and Vivien Chen will supervise the conduct of the study. Dr. Chen will be responsible for supervision of the ascertainment process and Dr. Fontham of the interviewing. Travel Costs Training Session (San Francisco) 3 persons at $1125 $3375 Abstracting - 25 hospitals X 20 miles X 18 trips X .21= $1890 48 Interviewing - 40 X 40 miles X .21/mile $ 336 Total $5601 6

R e~llY~~~ 1~loRa~~ ,a-ivc~- ~R,•-/*!~ ~PRINCIPAL INVESTIGATIjq/PROGRAM D1Rc::TORs rC1dy0 C:OZLea, M. D. W 0 To be named ci l ~ To be named (L To ~ be named ~ To be named cY' To be named DETAILED BUDGET FOR FIRST 12 MONTH BUDGET PERIOD DIRECT COSTS ONLY FROM 1-1-86 THROUGM 12-31-86 San NCCP/RCE Francisco DOLLAR AMOUNT REQUE$TED'(nmit tenr PERSONNEL (Applicant oiganization only) TIME /EFFORT NAME POSITION TITLE X Hours per Week SALARY FRINGE BENEFiTS TOTALS Pri ncipal lnve.tipstor D esearch Asso.II Interviewer II 20 Epi Interviewer I ~ echni. I 100 40 Of ' Assistant I 20 8 { L v 'L SUBTOTALS r CONSULTANT COSTS EQUIPMENT (ltemize) Video recorder and camera for interviewer training 2000 SUPPLIES (ltemize by category) 618 DOMESTIC 13021 TRAV EL FOREIGN T RE CO TS P T E INPATIENT ~ S A I N CA OUTPATIENT ALTERATIONS AND RENOVATIONS (Itemize by category) CONSORTIUM/CONTRACTUAL COSTS OTHER EXPENSES (lwmire by categoryl Telephone, $780 Rent, $3913 Data Processing, $1000 Specimen shipping, $345 TOTAL DIRECT COSTS (Also enter on page 1, item 7) PHS 398 (Rev, 5/82) PAGE 7 80415923 6,038 7r8-77 21,048 $92,885

l`I o K f~-~ e~r,t ~~ ~. 'N~a ~~a'~ PRINCIPAL INVESTI ATOR/r , DIR CT R: O r . a NCCP/RCE BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD DIRECT COSTS ONLY San Francisco BUDGET CATEGORY let BUDGET ADDITIONAL YEARS SUPPORT REQUESTED TOTALS PER IOD I!~ a~ 41 2nd' 3rd 4th 5th PERSONNEL rSN.ry and ~ frinpe bnnefirs.l b4oolieanc ory.niZ.won onlrl $ 61, 8 7 9 $ 6 3,12 3 $ 61, 8 51 ' CONSULTANT COSTS EGUtPMENT .~ O O O L SUPPLIES 618 -:7-z~4- -fr63- ooMESTIC 1,302 3,543 2,043 TRAVEL FOREIGN PATIENT INPATIENT CARE COSTS OUTPATIENT ALTERATIONS AND RENOV AT IONS CONSORT1UM/ CONTRACTUAL COSTS OTHER EXPENSES 6,038 --~}-~}- $71,837 $74,108 $71,626 TOTAL DIRECT CpSTS INDIRECT 29 3% MT . 21 714 r 206 r $92,885 $95,822 $92,612 TOTAL FOR ENTIRE PROPOSED PROJECT PERIOD (Also enter on page 1, item 8) $281,31 Direct + 9 Total Indirect JUSTfFICATION (Use continuation paqtrs if necessary): Describe the spacifie functions of the personn.l and consuttants.Jf a recvrrinq annual increase in personnel costs is anticipated, give the percentage. For all yeers, justify any costs for whicA the need may not be oDvious, such as equipment, foreig~ travel, alterations and renovations, and consoriiumlcontractual costs. For any additional years of support requested. justify any significant increases ~n any cateyory over the first 12 month budget period: ln eddition, for COMPETING CONTINUATION applications, justify any siqnificant increases Oyer the current levef of support. PHS 398 (Rev. 5/82) PAGE

. Z r~ a/ L ~ V~rzsr~+ e Nwen- INCIPAL INVESTIGATOR/ OGRAM L: -1; rl8a. Fsl'dy0 E Is ALTERATIONS AND RENOVATIONS flt+mits by ureyo.vl CONSORTIUM/CONTRACTUAL COSTS 80415925 OTHER EXPENSES (lremire by wreporyJ L ~ n~d uAq e1e~Q 64'd y/ Nce 300 aPT~'o~a~o 23S IeL h N p _M p e oo ~ ~ ~ p~} y rn e N~- ~c ~t c sPl~f-~ h s A/t Po v'j od iN Rer~[ZJs 375 DETAILED BUDGET FOR FIRST 12 MONTH BUDGET PERIOD TS ONLY O FROM 1-1-86 THROUGH 12-31-86 ACSC DIRECT C S Atlanta DOLLAR AMOUNT REQUESTED (Omrr cenr PERSONNEL (Applicanr oryanizarion only) TIME lEF FORT NAME POSITION TITLE % Hours p.r Week SALARY I FRINGE BENEFITS r TOTALS - Pr i nc i P al I hvett i qat or --- David Simon Helen C o Coordinator 20 8 Mr. Whitaker Pro rammer 40 16 TBN Interviewer 100 40 TBN Clerk/bata Entr 50 20 f 4-1 SUBTOTALS ~ CONSULTANT COSTS EQUIPMENT (Itrmizrl' / I7 M_ P ~- ~ O~/p v~~ 7/ n 0 a VT ld o Video ~altspL~y a/z~ /~-e c-c.rs aa 9 6ef SUPPLIES (lnmize by category) Consumable office supplies $120/month $1,440 ~ee g-a~s tauc~--'~elepk~er+e ~~ Postage 500 e o w~ U ~ ~- . i b 6 o~c .r / o e OMESTIC ' TRAVEL FOREIGN INPATIENT PATIENT CARE COSTS OUTPATIENT Cl l (-js) . TOTAL DIRECT COSTS (Also enter ompage 7, item 7) PHS 398 (Rev. 5/82) PAGE.9 571,20G . 11,631 82,835

~ m oo .~~ Ui'l: ir~~ PRINCIPAL INVESTIGKTQR/PROGRAf. / Cc+rrgg~ Pelago ACSC " BUDGET FOR ENTIRf PROPOSE._ .jJECT PERIOD DIRECT COSTS ONLY Atlanta BUDGET CATEGORY 1st BUDGET ADDITIONAL YEARS SUPPORT REQUESTED TOTALS PERIOD (from peyr Il' 2nd 3rd' 4th 5th PERSONNEi. (Safary and frinpe bendittl wplieanr om.ni:.rion onlPl 46,191 59,476 52,111 CONSULTANT COSTS EQUIPMENT SUPPLIES ~_ 0 DOMESTIC 7,228 5,704 2,728 TRAVEL , FOREIGN PATIENT INPATIENT CARE COSTS OUTPATI ENT ALTERATIONS AND RENOVATIONS CONSORTIUMI CONTRACTUAL COSTS OTHER EXPENSES ,,,~.~^~S .f ~,~ ~ ~ ~ - - r , , j , - r ,s r 71,204 73,475 63,250 TOTAL DIRECT COSTS 11,631 14,053 11,923 Indirect TOTAL FO $82,835 $87,528 $75,173 R ENTIRE PROPOSED PROJECT PERIOD /Also enter on paye 1, item 8) $ 245,53 6 Total Direct 6 Irsd,_irerr JUSTIFICATION (Use continuation pages if necessary): Describe tlte specific functions of the personnel and consultants. It a rewrring annual increas" in personnel costs is anticipated, give the percentage. For all years, justify any costs for which the need'may not be obvious, such as equipment• fore,g travel, alterations and renovations, and consortrum/contractual costs. For any additional years of support reduested, justify any significant increases ir any wtegory over the first 12 month budget period. In addition, for COMPETING CONTINUATION applications, justify any significant incraases ove .~ PHS 398 (Rev. 5BZ1 PAGE "10 O4-h eli 'Expentres c Z q w~ 4 379 p 1^ lras~+ S e/L v1 c-0- C-0 rt ~X4-c ~ ~- f o Ret4 V ~ 3 0o ~, 256 -Te L e p,4aN-vii ,G or ph4¢or- opy 09 •l/Z, r+\lrn -e N'F '~ Aasp I 4t~s # 37 s S eRt/i c v- e-. N4 ILRc~ ReN~ ~ ~IG TeLep A orrt~e- ~'600 tho~e~op.liK9 . 'soo the currsnt levet of support.