Document NGnZ9nq45935ex1DBBbXNxnw
EXXON CHEMICAL AMERICAS
P O Bom 3272. Mootton. TtMl 7700}
tMVttOMMENTAL APFAM* DEPARTMENT J P. TMORN
ejon CHEMICALS
July 24, 1981
AIHC Epidemiology Sub-Committee
Gentlemen:
Attached is the latest version of the University of Texas Gulf Coast brain tumor study proposal. This was submitted to NCI on July 1, where funds exist, at the specific encouragement of Dr. Richard Adameson who replaced Greg O'Connor last September as director of the Cancer Cause and Prevention Division.
.You will note that the sample size has been increased by the inclusion of Louisiana. The pathology element has also been significantly enhanced by .the addition of Dr. Pelayo Correa as a co-investigator.
Your individual comments/endorsement should be sent to reach Dr. Huffier by September 15 if possible. If you will copy your letters to me, it may be possible to add A.I.H.C.'s endorsement as well.
Very truly yours
CWU:skm
Attachment
cc: W. J. McCarville - w/o attachment
L. J. Guarraia - "
"
R. A. Lang
-"
C. W. Umland
a i Exxon Chemical company a>yt,.on 01 Exxon coapoaation
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THE UNIVERSITY OP TEXAS HEALTH SCIENCE CENTER AT HOUSTON
SCHOOL OF PUBLIC HEALTH
1 June 1981
Mr. Carl Umland Exxon Chemical Americas Post Office Box 3272 Houston, Texas 77001
Dear Carl:
Well, the new grant application is off to NIH with a request for assignment to the Special Programs Branch of NCI per Dr. Adameson's suggestion. I am enclosing a copy of the new application and my letter to Dr. Adameson for your review.
Since a number of AIHC member industries are interested in the proposed study, you may wish to circulate this new application for review. I would be extremely appreciative of any comments or suggestions provided by such a review since we will have until October 1981 to forward any additional consents in support of our application. I understand that Gulf, Texaco, Union Carbide and Monsanto, in addition to Exxon, are extremely interested in the proposed study.
Thank you again for your strong interest and continued support of our research endeavors.
With very best regards.
PAB/st Enclosures (2)
Patricia A. Buffler, Ph.D. Associate Dean for Research and Associate Professor of Epidemiology
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AiioctiH p--tor
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THE UNIVERSITY OP TEXAS HEALTH SCIENCE CENTER AT HOUSTON
SCHOOL OP PUBLIC HEALTH
1 July 1981
p. e. box HIM HOUSTON. TXXA* TWM
Dr. Richard AdameBon Acting Director Cancer Cause and Prevention Building 31, ll-A-03 National Cancer Institute Bethesda, Maryland 20209
4
Dear Dr. Adameson:
I appreciate the opportunity to talk with you several weeks ago, and the encouragement you provided for us to proceed with our request to NCI/NIH for funding for the proposed case-comparison study of CNS neuroglial tumors and occupational exposures in the Texas-Louisiana coastal area. Per our discus sion, I am enclosing a copy of the application submitted to NIH on July 1, 1981. In my letter of transmittal, I specifically requested that this application be assigned to the Special Programs Branch of NCI (Carcinogenesis Extramural Programs) as you suggested.
> I have discussed this request for Special Programs Branch assignment with Dr. Pelayo Correa, Principal Investigator for the Louisiana component of the proposed study, and he is in full support of your suggestion. If, upon your review of the enclosed application, you identify the need for or desire for any additional Information, please let me know.
Thank you again for your interest and thoughtful review of our proposed research.
With best regards.
Patricia A. Buffler, Ph.D. Associate Dean for Research and Associate Professor of Epidemiology
PAB/st Enclosure (l)
cc: Dr. Pelayo Correa, Louisiana State University Medical Center Dr. Robert Grossman, Baylor College of Medicine Dr. Ralph Frankowski, The University of Texas School of Public Health
bcc: Mr. Carl Umland
UCC 068584
DEPARTMENT F HEALTH AND HUMAN SERVICES PUEUC HEALTH SERVICE
ABSTRACT OF RESEARCH PLAN
LEAVE BLANK PROJECT NUMBER
NAME AND ADDRESS OF APPLICANT ORGANIZATION tSmmm mm Hum 71, pmpm J
University of Texas Health Science Center, P.0, Box 20036, Houston, Texas 77030
TITLE OF APPLICATION (Smmm mm Hmm 1,
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CNS tumors and occupational exposures
N*f Till* and Dtftrtntni *f *11 ^t*fuixwl ^r*anntl *fi9*|d an pj*cft htfimlnf (th Principal lnvitifali/Pt|tn Ofcactaf
Patricia A, Buffler, Ph.D,, Principal Investigator, Associate Dean and Associate Professor of Epidemiology
Ralph F. Frankowskl, Ph.D., Co-Investigator, Associate Dean and Professor of
Biometry Robert G. Grossman, M.D.. Co-Investigator, Professor and Chairman, Department
of Neurosurgery, Baylor College of Medicine J. Fred Annegers, Co-Investigator, Associate Professor of Epidemiology Robert Hardy, Ph.D., Co-Investigator, Professor of Biometry Merry Makela. Ph.D., Co-Investigator, Research Assistant Professor Susan Wood, M.A., Project Director, Epidemiology Research' Unit Lindsay Reed, M.S., Data Processing Director, Epidemiology Research Unit
Keith Burau, Ph.D., Computer Programmer, Epidemiology Research Unit Clayton Eifler, Ph.D., Co-Investigator, Assistant Professor of Biometry
(See Page 2a for Continuation)
ABSTRACT OF RESEARCH PLAN: CacIiIv <UcriW tft#
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* In collaboration with the Louisiana State University Medical Center, a popula tion based case-control interview study of newly diagnosed histologically confirmed CNS neuroglial tumors among adults aged 20-79 years will be conducted in the six county Texas Gulf Coast Area and twenty-six parishes in southern Louisiana. Cases of CNS neuroglial tumors diagnosed during the interval July 1979 to June 1984 will be ascertained through existing systems of case ascertainment in the two study areas (Texas and Louisiana). An estimated 954 cases of neuroglial tumors will be identified and all available tissue specimens will be reviewed by collaborating neuropathologists In the two study areas. A population based comparison group, matched on age, race and sex, will be selected In the two study areas. Detailed personal interviews with case and comparison subjects will be conducted to ascertain occupational, residential, radiological and familial exposures and to estimate the relative risk of neuroglial tumors associated with these risk factors. In the event of death or disability, interviews will be conducted with next of kin,:.
Incidence rates for neuroglial tumors for the Interval July 1979-June 1984 will be estimated and compared for the two study areas and for specific Texas counties and Louisiana parishes. A detailed occupational and industrial coding scheme will be used to facilitate Identification of high risk occupations and industries In the two study areas. Interview data from the two study areas will be analyzed separately and combined, as indicated by initial analyses. Data regarding familial aggregation will be validated by use of mailed questionnaires, death certificates
and hospital records.
LABORATORY ANIMALS INVOLVED. IdmtMfy hr
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Patricia A. Buffier, Ph.D.
Case-comparison study of neuroglial tumors and occupational exposures In Coastal Texas and Louisiana.
ABSTRACT OF RESEARCH PLAN (CONTINUED)
Name, Title and Department of all professional personnel engaged on project, beginning with Principal Investigator/Program Director:
Louisiana Component PeTayo Correa, M.D., Co-Investigator, Professor of Pathology William D. Johnson, M.D., Co-Investigator, Associate Professor of Biometry Paul McGarry, M.D., Co-Investigator, Professor of Pathology Elizabeth T. Fontham, M.P.H., Co-Investigator, Instructor of Pathology
Page 2a
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BUFFLER, Patricia k
188-30-2040
| TABLE OF CONTENTS
' Page
SECTION 1
Face Sheet........................................................................................................................................................1 Abstract ......................................................................................................................................................... 2 Table of Contents.......................................................................................................................................... 3 Detailed Budget for First 12-MonthBudget Period .............................................................. 4 Budget Estimates for All Years ofSupport .................................................................................. S Biographical Sketch - PrincipalInvestigator ............................................................................ 9 Other Biographical Sketches ........................................................................................................... 12 Other Support.................................................. ......................................................................................... 42 Resources and Environment ................................................................................................................. 44
SECTION 2. RESEARCH PLAN
A. Specific Aims........................................................................................................................................46 B. Significance........................................................................................................................................46 C. Previous Relevant Research and Preliminary Studies ....................................................... 53 ,D. Research Plan........................................................................................................................................ 62 E. Permission to Investigator Human Subjects ........................................................................... 86 F. Consortium and Collaborative Arrangements ........................................................................... 87 . G. Literature Cited ................................................................................................................................ 88
CHECKLIST............................................................................................................................................................ 92
APPENDICES
A. Hospitals in the Six-County Area of Texas ......................................................................... B. Hospitals in Southern Louisiana .............................................................................................. C. Hospital Abstract Form........................................... ........................................................................ D. Histopathologic Evaluation Form.................................................................................*. . E. Sample Questionnaire ........................................................................................................................ F. Consent Forms ..................................................................................................................................... G. Letters of Support for Collaborative Arrangements .....................................................
Page 3
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Appendix 6
LOUISIANA STATE UNIVERSITY MEDICAL CENTER
1901 Perdido Street New Orleans, LA 70112
Department of Pathology
June 25, 1981
Dr. Patricia A. Buffler Epidemiology Research Unit School of Public Health The University of Texas Health Science .
Center at Houston P.0. Box 20186 Houston, Texas 77025
Dear Dr. Buffler:
Z have enjoyed working with you and your team in the preparation of our application for an NCI grant to carry out a case-control study * of neuroglial tumors in Texas and Louisiana. This subject is of considerable interest to me and my staff and we hope to have the opportunity to work with you in this investigation. As you know, we are carrying out case-control studies in Louisiana and have established the necessary contacts with hospitals and medical personnel.
We have obtained approval of the administrative authorities of our University to enter in a consortium agreement with the University of Texas for this investigation.
Looking forward to our collaborative research effort.
s:
FC:ac Enclosure
Pelayo
D
Professor of Pathology
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School of Allied Health Professions School of Graduate Studiee
School of Medicine in Shreveport
School of Demisry
School of Medicine in New Orleans School of Nursing
Cmmput Corrtipondffic*
fr^m: Dr. Pelayo Corr
Pathology Depar
Mr. William Rol Comptroller
Louisiana state University
MEDICAL CENTO.
June 5, 1981
We'plan to enter aVitt a consortium agreement with the University of
*
Texas to apply for a grant to study the epidemiology of brain tumors. 4*
I vill appreciate it if you let me know if the enclosed consortium
agreement meets with your approval.
FC:ac Enclosure
UCC 068589
Baylor College of Medicine
DEPARTMENT OF PATHOLOGY *713 7904661
June 30, 1981
Dr. Patricia A. Buffler Epidemiology Research Unit * School of Public Health The University of Texas Health Science
Center at Houston Texas Medical Center Houston, Texas 77030 Dear Doctor Buffler:
This letter Is to affirm the willingness of the Department of Pathology of Baylor College of Medicine to collaborate In your proposed investigation of brain cancer In the Texas Gulf Coast Area. Your pro posal has been reviewed by Dr. Robert Grossman, Dr. Dawna Arnstrong, Dr. ` Dan Sauls, and Dr. Joel Kirkpatrick, the persons primarily Involved in the direction of the study and the Department of Pathology is prepared to support then by providing the facilities and personnel necessary. The estimated cost for the pathological studies (including technical end secretarial assistance) for the three years of the Investigation Is approximately $17,200.
The Department of Pathology at Baylor College of Medicine Is pleased to cooperate with you and your colleagues In this worthwile Investigation.
JLT :mn
TEXAS MEDICAL CENTER HOUSTON. TEXAS 77030
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Robert Bernstein, M.D., FACP. Commissioner A. M. DonnellJr,, M.0, M,P.H,, FJLC.P. Deputy Commissioner ! .
October 31, 1980
1100 West 49th Street Austin. Texas 78756
` (512) 458-7111
Patricia A. Buffler, Ph.D. Associate Professor of Epidemiology ' The University of Texas Health Science Center \ School of Public Health * Epidemiology Research Unit
P.0. Box 20186 Houston, Texas 77025
Member* of the Board
William |. Foren, Chairman Laurence N. Mickey, Vicr-Ouirmin Rodcrle M. Bell, Secretary Johnnie M. Benton H. Eugene Brown Sitter Bernard Marie Borjmeyer Ramiro Caiso Charter Max Cole Frincl! A. Conley Ben M. Durr Raymond G. Garrett Bob 0. Glare, Blanchard T. Hollins Robert D. Moreton Joe N. Pyle Richard W, Rapdale Isadora Roosth Barbara T. Slever
Dear Doctor Buffler:
Thank you for your letter of October 14 indicating your interest in applying for a National Institutes of Health Contract. We certainly agree that "Occupational Exposure and Brain Cancer in Texas Coastal Counties" is a major problem that would benefit investigation. The Statewide Cancer Registry Program will be happy to negotiate in assisting with this proposed study.
It is my understanding that you are interested in all brain cancer cases between 1979-1980, and that you hope to gather data on all glioma cases for the years 1981-1984.
We look forward to cooperating in this very important project.
In order for the Texas Department of Health to determine its role in dealing with the many problems related to cancer and the environment, I am convening an ad hoc committee of experts ueh as yourself to brainstorm with us at a meeting on November 20. I have mailed an invitation and agenda to Dean fwuul Stallones. We hope that you can participate.
Most sincerely.
^ _ <ut\ j
-----
Robert Bernsi ein , m.dT, f.a.c.p.
Commissioner of Health
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FRANCINt JtNStN. MB. MJFM. MMTM
I
HARRIS COUNTY HEALTH DEPARTMENT
2370 RICE BOULEVARD. BOX 25248 HOUSTON. TEXAS 77005
December 17, 1980
(Till
Patricia A. Buffler, Ph.D. Associate Dean for Research and Associate Professor of Epidemiology School of Public Health University of Texas *Bealth Science
Center at Houston F. 0. Box 20186 Houston, Texas 77025
Dear Dr. Buffler:
i In response to your proposal to National Institute of Health for a five year population based study of intra-cranlal tumors among residents of Harris and surrounding counties, ve would like to offer our support and the expertise we have available for your study.
This Is a particularly timely study in view of the rapid in flux of new residents coupled with the Increased suspicion, supported by Investigation and reporting, of health problems caused by chemical pollutants, both air and water, in this area.
mac
JCC 068592
Public Health Department ms North MacGregor Houston, Texas 77030
-*%f
HOUSTON
JIM McCONN, Mayor
Houston. Texas 77001
December 15, 1280
CITY COUNCIL MEMBERS
Larry McKaiele Eirnt McGowen. It. Lance Lalor Antnont W. Hall. Ji FtANK O. Mancueo JOHNNY G. Goodner Cnrktin Haredhg Dali M. Catnrwti ItiiT Rms Jim Westmoreland Eleanor Tin*let Johnny Goten Home* L Ford Jt/DRON RoRtNSQN, Jk.
CITY CONTROLLER
Kathryn J. Whitmire
\
Patricia A. Buffler, Ph.D. Associate Professor of Epidemiology University of Texas School of Public Health P.O. Bax 20186 Houston, Texas 77025
Dear Dr. Baffler;
t The Houston Health Department would like to offer support and whatever assistance it can make available to your proposed study of the incidences of intracranial tumors in the Texas Gulf Coast Area.
Widespread publicity about the apparent increased risk of such tuiors in association with exposure to petrodWiical industries has created an urgent need for more definitive research.
Your proposed study is well designed and should give us the ansv^rs we need to support additional efforts to protect the health of area residents.
Sincerely,
JC/BHVan
/y Judith Craven, M.D. C/ Director of Public Health
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LOUISIANA STATE UNIVERSITY MEDICAL CENTER
1901 Perdido Street
New Orleans, LA 70112
II
Department of Pathology
/
June 26, 1981
Patricia A. Buffler, Ph.D. Epidemiology Research Unit School of Public Health The University of Texas Health
Science Center at Houston P.0. Box 20186 Houston, Texas 77025
Dear Dr. Buffler:
In our studies of cancer epidemiology in Louisiana ve have made extensive use of computer tapes supplied by the Louisiana Department of Motor Vehicles giving information about driver's license holders. * We have in our hands a tape with this information up to 1978 and we do not anticipate any problems in obtaining an update of the tape if the brain cancer study is funded. The Department of Motor Vehicles updates the computer tape of driver's license holders very often and we have found in the past that the information on the tape is very reliable.
Sincerely yours, euD
FC:ac
PelayoLCorrea, M.D. Professor of Pathology
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School of AKed Health Professions School of Graduate Studios
School of Medicine in Shreveport
School of Dentistry
School of Medicine in New Orleans School of Nursing
f
-
F&CM: TO:
RE:
LOUISIANA STATS UNXVSSSITT
*
MEDICAL CENTEX
LSU Institutional Review Board
John C. Finerty, Vice-Chancellor Responsible Officer for Human Subject* LSU Medical Center
Grant Application By: Felayo Correa, M.D.
Entitled: Occupational Exposures and Intracranial Tumor* In Coastal Texas
and Southern Louisiana - La. Component__________________ __
This is to document review of the above research proposal. In the judgement of this Board, the procedures delineated In said application conform to the pertinent DBEff rules and regulations regarding use of human subjects*
THE INVESTIGATOR agrees to report to the Committee any emergent problems, serious adverse reactions, or procedural changes that may affect the status f the Investigation, and that no such change will be without Board approval, except where necessary to eliminate apparent Immediate hazards* The investigator also agrees to periodic review of this project by the Board at intervals appropriate to the degree of risk to assure that the new project is being conducted in compliance with the Board's understanding and recommendations.
Records regarding action of the Board, referable to said project, are on file in the office of the Chairman.
DATE OF APPROVAL:
_______________________________
Principal Investigator
DATE:
6 - '$/
a Lgnon V. J;
M.D., Chairman
DATE:
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LOUISIANA STATE UNIVERSITY MEDICAL CENTER
1901 Perdido Street'
New Orleans, LA 70112
Department of Pathology
June 15, 1981
Ms. Susan Wood University of Texas Health Science Center School of Public Health 6905 Bertner Houston, Texas 77030
Dear Ms. Wood,
Dr. Pelayo Correa has asked me to communicate with you concerning our proposed pathologic studies in connection with the project "Occupational Exposures and Intracranial Tumors in Southern Louisiana and Texas--Louisiana Component". I would like to express my interest in collaborating with you. We estimate that these studies would involve recutting, staining, and examining the paraffin blocks from 500 to 600 cases over a period of three years. Our attempt would be to determine the types of tumors involved and to classify them probably utilizing the World Health Organization classification. This would involve considerable technical work as well as visits to hospital laboratories in Louisiana and a good deal of professional time in examining the many slides involved. I have submitted to Doctor Correa a budget proposal.
I believe this would be an interesting study of the pathologic features involved in neoplasms under these circumstances. We will be searching for a connection between the occurrence of brain tumors and petrochemical exposure.
I would be expecting to collaborate with pathologists in your area, exchanging slides and data.
Sincerely,
PMbb
cc: Dr. Correa. Terry Fontham.
Professor of Pathology
School of ADM Health Professions School of Dentistry
School of Graduate StixJiea School f Medicine in New Orleans
School of Madieina in Shreveport
School of Nursing
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