1 15 1 https://www.nal.usda.gov/exhibits/speccoll/files/original/623b4cbd8cd7ce67137660edb190fc1d.pdf 772408bd938746d030ed31e62d46c8bf PDF Text Text Item ID Number 01771 AllthOT Blair, Aaron Corporate Author Typescript: Research Protocol, a Case-Control Study of Lymphoma and Soft-Tissue Sarcoma: Association with Herbicide Exposures, [nd] Journal/Book Title Year 000 ° Month/Day Color Number of Imaoes : 16 Descrlpton Notes Monday, June 11, 2001 Page 1772 of 1793 �Research Protocol A CASE-CONTROL STUDY OF LYMPHOMA AND SOFT-TISSUE SARCOMA: ASSOCIATION WITH HERBICIDE EXPOSURES Aaron B l a i r S h e l i a K. Hoar E n v i r o n m e n t a l E p i d e m i o l o g y Branch N a t i o n a l Cancer Institute Landout 3C06 Bethesda, Maryland 20205 �A Case-Control Study of Lymphoma and Soft-Tissue Sarcoma: A s s o c i a t i o n w i t h H e r b i c i d e Exposures I. Introduction The E n v i r o n m e n t a l E p i d e m i o l o g y Branch of the National Cancer Institute is p l a n n i n g to conduct an e p i d e m i o l o g i c case-control i n v e s t i g a t i o n of soft-tissue sarcoma (STS), non- Hodgkin's lymphoma (NHL), and Hodgkin's disease (HD). The cases and controls, or t h e i r next-of-kin» w i l l be interv i e w e d by telephone to o b t a i n occupational h i s t o r i e s and other i n f o r m a t i o n p e r t i n e n t to the o r i g i n s of these cancers. P a r t i c u l a r attention w i l l be p a i d to h e r b i c i d e exposures. II. O b j e c t i v e The objective of t h i s study is to evaluate the effects of the f o l l o w i n g factors on the development of STS, NHL, and HD: 1) O c c u p a t i o n a l and non-occupational exposure to h e r b i c i d e s , in p a r t i c u l a r p h e n o x y a c e t i c a c i d s and c hloropheno1s. 2) Exposure to p h e n o x y a c e t i c a c i d - c o n t a i n i n g drugs, eg. c l o f i b r a t e . 3) Other factors such as g e n e t i c syndromes, f a m i l i a l c l u s t e r i n g , i m m u n o l o g i c d e f i c i e n c y , lymphedema, t r a u m a , and exposure to r a d i a t i o n , a r s e n i c , v i n y l c h l o r i d e , a n d r o g e n i c - a n a b o l i c steroids, a l l e r g e n i c extract i n j e c t i o n s , and a n i m a l s susceptible to �sarcoma-inducing viruses. III. L i t e r a t u r e R e v i e w Certain h e r b i c i d e s and h e r b i c i d e - c o n t a m i n a n t s been associated w i t h teratogenesis, have mutagenesis, and c a r e i n o g e n e s i s in a n i m a l and b a c t e r i a l e x p e r i m e n t s (Young AL et al., 1978). Recent e p i d e m i o l o g i c s t u d i e s from Sweden suggest that persons exposed to h e r b i c i d e s may at excess r i s k of cancer. be A retrospective cohort study of r a i l r o a d workers exposed to a m i t r o l e (3-am5no-1»2,4triazole) a n d p h e n o x y a c e t i c a c i d s ( 2 » 4 - d i c h l o r o p h e n o x y a c t i c a c i d and 2,4,5-trichlorophenoxyacetic a c i d ) showed of cancer L, i n c i d e n c e and m o r t a l i t y (Axelson 1974; Axelson 0 et a l . » 1980). and chlorophenols and (Hardell L and Sandstrom A, 1979; Hardell risks were whether L STS, 1979; et al., 1981). to were Sundell phenoxyacetic N H L , and Eriksson M HD et al., For all three cancers, increased f i v e - to s i x - fold, exposures 0 and Case-control studies revealed a s s o c i a t i o n s between exposure acids elevated rates regardless of c o n t a m i n a t e d by p o l y c h l o r i n a t e d d i b e n z o d i o x i n s (PCDDs) and dibenzofurans (PCDFs). There is w i d e s p r e a d p o t e n t i a l for exposure to phenoxy- a c e t i c a c i d s and chlorophenols. In a d d i t i o n to h e r b i c i d e f o r m u l a t i o n s these c h e m i c a l s appear retardants used in b l u e s t a i n i n s a w m i l l s , s l i m e control p r e p a r a t i o n s in paper and p u l p m a n u f a c t u r i n g , c u t t i n g o i l s and f l u i d s , wood p r e s e r v a t i v e s , waterproofing agents for leather and t e x t i l e s , and in m e d i c a t i o n s . Clofibrate, a plasma l i p i d - �l o w e r i n g d r u g * is a p h e n o x y a c e t i c a c i d - d e r i v a t i v e and has i n d u c e d h e p a t o c e l l u l a r c a r c i n o m a s and sarcomas boda and Azarnoff, 1979). If the reported in rats (Svo- epidemiologic associations are causal and as strong as suggested by the Swedish research, these agents could be r e s p o n s i b l e for a large p r o p o r t i o n of the cases of STS, NHL, and HD in the U n i t e d States. The e t i o l o g y of STS is largely unknown. A small propor- t i o n of cases are related to M e n d e l i a n syndromes and f a m i l i a l m u l t i p l e - c a n c e r syndromes (Tucker and F r a u m e n i , 1981; Li and F r a u m e n i , 1969; associated Blattner with et a l . » 1979). genetically Some cases are determined i m m u n o d e f i c i e n c y syndromes and i a t r o g e n i c immunosuppressed states (Hoover and F r a u m e n i , 1973; Spector et al., 1978). K i n l e n et al., 19797 C h r o n i c l y m p h e d e m a has been l i n k e d to sarcomas in case reports (Dubin et al., 1974). E x t e r n a l r a d i a t i o n therapy and r a d i o i s o t o p e s have also been associated w i t h the d e v e l o p m e n t of sarcomas ( K i m et al., 1978). Thorotrast, used for r a d i o g r a p h i c s t u d i e s of blood vessels in the l i v e r , resulted sarcomas in a n g i o s a r c o m a s of the l i v e r and at the s i t e of i n j e c t i o n (da Motta et al., Falk et al., 1979a). 1979; Use of the r a d i o isotope, 1-125, for treatment of t h y r o t o x i c o s i s was followed e i g h t years later by the d e v e l o p m e n t of a sarcoma al., 1978). and suspected of the larynx ( M c K i l l o p et Other agents used m e d i c i n a l l y and o c c u p a t i o n a l l y of b e i n g associated w i t h d e v e l o p m e n t of STS i n c l u d e ! a r s e n i c , v i n y l c h l o r i d e , a n d r o g e n i c - a n a b o l i c steroids, i r o n - d e x t r a n i n j e c t i o n s , and a l u m i n u m compounds (Falk et al., �1979b, M c l l l m u r r a y and L a n g m a n , 1978; W e i n b r e n et al.,1978) V i r u s e s appear to be r e s p o n s i b l e for the i n d u c t i o n of sarcomas in c h i c k e n s * cats, and m i c e and may play a role in the causation of human sarcoma (Kufe et a l . » 1972)» a l t h o u g h there is no e p i d e m i o l o g i c e v i d e n c e to date. E p i d e m i o l o g i c studies have also suggested possible l i n k s between these diseases and selected occupations (Grufferman et al., 1976, Tucker and F r a u m e n i » 1981). Woodworkers* c l e r i c a l workers, accountants* engineers, lawyers, judges, p h y s i c i a n s , and t e x t i l e workers reportedly have an increased r i s k of HD, Several, but not a l l , cohort s t u d i e s of c h e m i s t s have demonstrated excess m o r t a l i t y from HD and NHL (Li et a l . » 1969; O l i n , 1976; O l i n , 1978; Searle et al., 1978; Hoar and Pell, 1981 ). Non-occupational factors associated w i t h HD and NHL i n c l u d e age, race, sex, g e o g r a p h i c a l l o c a t i o n (Cole and MacMahon, 1968), socioeconomic status, m a r i t a l status, e t h n i c i t y , r e l i g i o n , o b e s i t y , s m o k i n g h i s t o r y , coffee d r i n k i n g h a b i t s (Paffenbarger et al., 1977; Paffenbarger et al., 1978), f a m i l i a l cancer h i s t o r y , d i a b e t e s (Kalant and Seemayer, 1979), s y s t e m i c lupus erythematosus (Green et al., 1978), i n f e c t i o u s m o n o n u c l e o s i s (Carter et al., 1977), c e l i a c d i s e a s e (Douglas, 1977), i m m u n o d e f i c i e n c y syndromes ( F i l i p o v i c h et al., 1980), tonsi1lectomy (Gutensohn et al., 1975), i o n i z i n g r a d i a t i o n , c h e m o t h e r a p y (Krik o r i a n et al., 1979), i m m u n o s u p p r e s s i v e drugs (Hoover and F r a u m e n i , 1973), and other exposures. �Many factors h a v e been suggested as c o n t r i b u t i n g to the d e v e l o p m e n t of STS, NHL, and HD but need to be further e v a l u a t e d and q u a n t i f i e d . In p a r t i c u l a r , the heavy use of h e r b i c i d e s a n d t h e h i g h cancer r i s k p o s s i b l y associated w i t h t h e i r exposure underscores the urgent need to conduct an independent ep i detn i olog i c i n v e s t i g a t i o n of persons exposed to these p e s t i c i d e s . IV. Study Subjects 1) The case group w i l l consist of w h i t e men, aged 21 and older, d i a g n o s e d w i t h STS, NHL, or HD, from a r e g i o n where at least 10% of the w o r k i n g w h i t e p o p u l a t i o n has been engaged in o c c u p a t i o n a l a c t i v i t i e s that i n v o l v e contact w i t h h e r b i cides. Kansas has been selected since it is a w h e a t - p r o d u c i n g area where h e r b i c i d e use is great but use of i n s e c t i c i d e s and f u n g i c i d e s is c o n s i d e r a b l y less. The goal is to select 200 cases of each cancer, however because the study region is sparsely populated and these are rare tumors, a m i n i m u m of 100 cases of each cancer w i l l be acceptable. Cases from the last f i v e years w i l l be drawn from the U n i v e r s i t y of Kansas M e d i c a l Center Cancer Data S e r v i c e , a p o p u l a t i o n - b a s e d cancer r e g i s t r y . Next-of-kin w i l l serve as respondents for those cases who h a v e d i e d . 2) The controls w i l l be w h i t e men from the general p o p u l a t i o n of the g e o g r a p h i c area selected for study. Three controls w i l l be matched to each case on age (+/yearn), v i t a l status, and area of residence (probably a 2 �m u l t i - c o u n t y unit). For cases who are currently a l i v e , controls aged 65 years or older w i l l be selected from the Health Care F i n a n c i n g A d m i n i s t r a t i o n f i l e * to be p r o v i d e d by NCI; whereas, controls aged 64 years or younger could be selected by telephone t h r o u g h a random d i g i t d i a l i n g t e c h n i q u e . For cases who have d i e d before the i n i t i a t i o n of the study* the controls could be selected from Kansas state m o r t a l i t y files. In a d d i t i o n to age at death (+/- 2 years)» these controls would be matched to the cases on year of death. Persons whose cause of death is STS, NHL, HD, or a m a l i g n a n c y of an i l l - d e f i n e d s i t e (ICDA code 195) would be excluded. The next-of-kin w i l l be i n t e r v i e w e d . The same controls should be used for the three case series whenever p o s s i b l e . The goal is that each case h a v e three s u i t a b l y matched controls for c o m p a r i s o n . We anti- c i p a t e that 700 to 1000 controls w i l l be necessary to meet t h i s r e q u i r e m e n t . A s s u m i n g an level of .05 and 10% of the p o p u l a t i o n exposed to h e r b i c i d e s , a study of 100 cases w i t h a 3:1 m a t c h i n g r a t i o would be able to detect a m i n i m u m odds r a t i o of 2.7 w i t h 90% power. V. Pathology R e v i e w Pathology blocks, s l i d e s , and/or m e d i c a l records w i l l be o b t a i n e d for c o n f i r m a t i o n of the d i a g n o s i s of STS, or HD. NHL, S p e c i m e n s w i l l be r e v i e w e d by NCI p a t h o l o g i s t s . �VI. Interv i ew The cases and controls, or t h e i r next-of-kin, w i l l be i n t e r v i e w e d by telephone c o n c e r n i n g the f o l l o w i n g items: Date of b i r t h Place of b i r t h Mar i tal status Religion Ethnicity Height/Weight Education O c c u p a t i o n (emphasis on exposure to p h e n o x y a c e t i c acids, chlorophenolsi arsenic compounds, v i n y l c h l o r i d e , poultry, other b i r d s , and cats) N o n - o c c u p a t i o n a l use of h e r b i c i d e s Smok i ng Coffee d r i n k i n g Fam i 1 i a 1 cancer Trauma Present or past m e d i c a l c o n d i t i o n s (diabetes, eczema, a l l e r g i e s , chloracne, v a r i c e l l a [ c h i c k e n pox], s y s t e m i c lupus erythematosus, i n f e c t i o u s m o n o n u c l e o s i s , celiac disease, immunodeficiency syndromes) M e d i c a l treatments (phenoxyacetic a c i d - c o n t a i n i n g drugs, t o n s i l l e c t o m y , i o n i z i n g r a d i a t i o n , chemotherapy, immunos u p p r e s s i v e therapy, allergy shots, �vaccines, iron-dextran injections, a n d r o g e n i c - a n a b o 1 i c s t e r o i d s » Fowler's solution* amphetamines, diphenylhydanto i n, etc . ) VI. Proposed Study Steps 1. O b t a i n d e m o g r a p h i c , a g r i c u l t u r a l , and i n d u s t r i a l charact e r i s t i c s of the g e o g r a p h i c area from w h i c h the cases and controls w i l l be selected. 2. Develop an i n t e r v i e w schedule. Conduct a pretest and make necessary r e v i s i o n s . 3. O b t a i n necessary clearance for the i n t e r v i e w schedule and project protocol from the NCI E n v i r o n m e n t a l E p i d e m i o l o g y Branch T e c h n i c a l E v a l u a t i o n of Projects and Q u e s t i o n n a i r e s C o m m i t t e e , the Office of Management and Budget, state v i t a l records offices, and p a r t i c i p a t i n g hospitals. 4. Identify the w h i t e men, aged 21 years or older, who were d i a g n o s e d w i t h STS, NHL, or HD, and who r e s i d e d in the g e o g r a p h i c area selected for study. Select the cases from the f i v e most recent years. 5. Select three controls per case, m a t c h i n g on age (+/- 2 years), v i t a l status, year of d i a g n o s i s or d e a t h , and area of r e s i d e n c e (probably a m u l t i - c o u n t y u n i t ) . p o p u l a t i o n controls u s i n g HCFA f i l e s , random d i g i t d i a l i n g , and Kansas state m o r t a l i t y f i l e s . Use the Draw �same controls for the three case s e r i e s whenever possible. 6. O b t a i n c o p i e s of death c e r t i f i c a t e s for deceased cases and controls. 7. O b t a i n and r e v i e w pathology blocks, s l i d e s , and/or m e d i c a l records for c o n f i r m a t i o n of the d i a g n o s i s . 8. Develop t r a i n i n g and procedure manuals for s u p e r v i s o r s i i n t e r v i e w e r s * abstractors* and coders. 9. Locate cases and controls* or t h e i r next-of-kin. 10. Prepare i n t r o d u c t o r y and informed consent letters and o b t a i n consent of cases and controls* or t h e i r nexto f - k i n * p r i o r to c o n d u c t i n g i n t e r v i e w s * in accordance w i t h e x i s t i n g federal, state, and local r e g u l a t i o n s . 1 1 . H i r e a n d t r a i n s u p e r v i s o r s * i n t e r v i e w e r s , abstractors* and coders. 12. Conduct telephone i n t e r v i e w s of the cases and controls, or t h e i r next-of-kin. 13. O b t a i n c o r r o b o r a t i v e e v i d e n c e of h e r b i c i d e exposure from resources, such as employers, employees, or a g r i c u l t u r a l a g e n c i e s , for study subjects suspected of h a v i n g such exposure. T h i s i m p o r t a n t step w i l l reduce p o t e n t i a l observer b i a s i n t r o d u c e d by i n t e r v i e w e r s aware of the �study hypothes i s 14. R e v i e w , e d i t , and code all completed 15. Analyze the data. 16. W r i t e a f i n a l report 17. 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J N a t l Cancer Inst 60: 89-92, 1978. j Searle CE, W a t e r h o u s e J A M , Henman BA, et al.: E p i d e m i o l o g i c a l study of the m o r t a l i t y of B r i t i s h c h e m i s t s . B r i t J Cancer 38: 192-193, �1978. Spector BD, Perry GS, Kersey JH: G e n e t i c a l l y d e t e r m i n e d i m m u n o d e f i c i e n c y diseases (GDID) and m a l i g n a n c y : R e p o r t from the immunodeficiency-cancer registry. 11: 12-29, C l i n Immu.nol Immunopath 1978. Svoboda DT and Azarnoff DL: Tumors in male rats fed ethylchlorop h e n o x y i s o b u t y r a t e , a h y p o l i p i d e m i c drug. Cancer Res 39: 3419-3428, 1979, Tucker MA and F r a u m e n i JF, Jr.: Soft tissue in Cancer E p i d e m i o l o g y and P r e v e n t i o n . D Schottenfeld and JF F r a u m e n i , Jr. (Eds). P h i l a d e l p h i a : WB Saunders Company, 1981 (in press). W e i n b r e n K » Salm R, Greenberg G: Intramuscular i n j e c t i o n s of iron compounds and o n c o g e n e s i s in man. Br Med J 1: 683-685, 1978. Young AL, C a l c a g n i JA, Thalken CE, et al.: The t o x i c o l o g y , e n v i r o n mental fate, and human r i s k of h e r b i c i d e Orange and its associated d i o x i n . USAF O c c u p a t i o n a l a n d E n v i r o n m e n t a l Health Laboratory T e c h n i c a l Report 78-92. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 066 Folder The folder containing the original item. 1771 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Blair, Aaron Sheila K. Hoar Title A name given to the resource Typescript: Research Protocol, a Case-Control Study of Lymphoma and Soft-Tissue Sarcoma: Association with Herbicide Exposures, [nd] Subject The topic of the resource case referent study lymphomas soft tissue sarcoma industrial exposure ao_seriesIII