New and Ongoing Epidemiologic Studies at TCR
New studies since 6/1/07
Christine Arcari, PhD
Infectious Disease Epidemiology Program
University of Texas Medical Branch at Galveston
Liver Cancer Cases in Texas, 2000-2004
TCR #07-272; TCR approval 7/30/07
The purpose of this study is to describe liver cancer cases in Texas, 2000-20004, in order
to understand the magnitude of the problem in different age, gender, and race/ethnic groups.
This data will be used to support a grant application on the etiology of liver cancer in Hispanics.
Patricia Bray, PhD
St. Luke’s Episcopal Health Charities, Houston
Breast Health Collaborative: Breast Health Information Web Portal
IRB #07-044; TCR #07-267; IRB approval 7/20/07
Funding source: St. Luke’s Episcopal Health Charities
The purpose of the project is to develop a geographically-based web site that allows those
who serve the underserved to refer clients needing breast health services to health providers.
This would also apply to the general population with access to internet services
We see this web site as a potentially important tool for health planners and community
health advocates, as well. The site will offer demographic, vital statistics and (hopefully) cancer
incidence data. The presentation of the data and information will include “thematic” mapping as
well as data reports or tables. Provider data and locations will be presented on this mapping as
well.
Taken with the resource information that is provided, we see the application of these data
as important for evidenced-based community health planning. People will be able to review the
data and visualize areas of greatest need. Due to the large and concentrated population in our
primary region of interest, we must be able to present data at sub-county levels of geography.
Census tracts, which in some cases will be aggregated in order to maintain confidentiality, would
be ideal.
Susan Carozza, PhD
Texas A&M University School of Rural Public Health
Feasibility of Stored Texas Newborn Screening Dried Blood Spots for Childhood Cancer
Epidemiologic Research
IRB #07-038; TCR #07-266; IRB exemption granted 6/29/07
Funding source: TCR
Dried blood spots (DBS) stored on filter paper have been used for some years in newborn
screening programs to test for the presence of potentially life-threatening inborn diseases. In
Texas, residual specimens remaining from this screening program are now being banked through
a collaboration of the Texas Department of State Health Services (DSHS) and the School of
Rural Public Health (SRPH) of the Texas A&M University (TAMU) Health Science Center.
Currently, this DBS bank contains specimens from July 2002 through December 2005. The bank
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is under the direction of Susan E. Carozza, PhD, Associate Professor in the SRPH Department of
Epidemiology & Biostatistics.
It is anticipated that these DBS will provide a rich resource for epidemiological research
into the causes of childhood cancers. In particular, these specimens can provide DNA for use in
evaluating the impact of genetic polymorphisms on disease risk. It is unclear, however, what
effect long-term storage at room temperature (as is the case with these samples) may have on the
stability of genomic DNA. We propose to conduct a study to determine the feasibility of
retrieving high-quality DNA from archival DBS for use in childhood cancer epidemiology
studies. In addition, this study will serve as a pilot epidemiological study to determine the
distribution of polymorphisms of the PON1 gene (a gene involved in the metabolism of
organophosphate pesticides) in a sample of childhood cancer cases and non-cancer controls.
Susan Carozza, PhD
Texas A&M University School of Rural Public Health
Pooled Analysis of Very Low Birth Weight and Childhood Cancers
IRB #07-052; TCR #07-350; IRB exemption granted 9/11/07
The primary aim of this study is to produce robust estimates of the risk of specific
childhood cancers following very low birth weight (VLBW: <1500 grams). Existing casecontrol datasets created for epidemiological studies of etiology of childhood cancers by linking
cancer and birth registries of five states will be pooled for analysis. Unconditional logistic
regression will be used to describe the association of VLBW with childhood cancer types defined
by the International Classification of Childhood Cancers(1), adjusting for gestational age,
plurality, sex, race/ethnicity, year of birth, parental age, and parental education. This project
requests approval to pool de-identified data from a previous DSHS IRB- approved study
(Agricultural Pesticides & Risk of Childhood Cancers, IRB #01-036), adding two newly
requested fields with data from other statewide sources.
Linda Elting, DrPH
University of Texas M.D. Anderson Cancer Center
Disparities in Access to Screening Mammography in the Rural South
TCR #07-301; TCR approval 8/23/07
Funding source: Susan G. Komen for the Cure
Breast cancer is the most common cancer among U.S. women and disparities in access to
screening and care are known to exist. Our research has the ability to inform and influence breast
cancer screening policy. If we find, as expected, that minority women in rural areas are
disadvantaged by lack of access, we will prepare reports for local health authorities with
suggestions for placement of mammography facilities. If we discover that lack of access does
not disadvantage rural women, that information will also be reported to permit re-allocation of
local funds to services that can influence breast cancer outcomes, such as improving policy
directly, by communicating with those who elect them- the lay public.
Data will be obtained for a 5-year period (2000-2004). Mammography facility data will
be obtained from FDA through a Freedom of Information Act request, including facility name
and address, category (federal, non-federal), type (office, hospital, clinic, mobile), and number of
mammography machines. We recently obtained data for 3 Southern states (Texas, Florida,
Louisiana) using this strategy. Screening rates will be obtained from the Behavioral Risk Factor
Surveillance System from CDC. Data on breast cancer cases, by stage at diagnosis and race, will
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be obtained directly from registries and instructions for preparing the data transfer file are
contained in Appendices F-H of the protocol. County-specific socioeconomic data from the 2000
US Census will be obtained from the Census Bureau’s Area Resource File. Variables of interest
include median household income, the age, race and ethnic distribution of women over age 40,
the number of women over age 40 who graduated from high school and spoke a language other
than English at home, and the number of household with insurance and access to a car.
Mammography facility data, screening data, census data, and cancer registry data will be linked
at the county level using county FIPS code (Federal Information Processing System code) which
is present or can be derived from each of the data sets.
Gary Marsh, PhD
University of Pittsburgh
Epidemiology and Biostatistical Component of the Pratt & Whitney Cohort Mortality and
Cancer Incidence Study
IRB#07-039; TCR #07-354; IRB approval 9/18/07
Funding source: Pratt and Whitney
In May 2000, the Connecticut Department of Public Health (CDH) began an
investigation of a suspected cluster of brain cancer at the Pratt & Whitney (P&W) engine
manufacturing plant in North Haven, CT. By August 2001, the CDH investigation had identified
14 cases of primary, malignant brain cancer, all of which were confirmed by the CT Tumor
Registry Program. All cases occurred among white male workers, and 12 of the 14 cases were
of a common type (glioblastoma). A preliminary comparative cancer incidence analysis
conducted by the CDH suggested that 14 cases was probably excessive and the CDH
recommended that a more comprehensive and rigorous investigation be undertaken by an
independent research group. The proposed historical cohort study was designed as the
epidemiological platform for a comprehensive and rigorous evaluation of the suspected brain
cancer excess among current and former P&W employees. The nested case-control study is an
exploratory study that will investigate whether the perceived brain cancer excess at the North
Haven plant can be related to factors internal and/or external to employment at the facility.
The primary research objectives of the proposed study are: 1) To identify and confirm
systematically any additional malignant, primary brain cancer cases and deaths that may have
occurred among subgroups of the P&W workforce not covered by the CDH preliminary
investigation. 2) To determine definitively whether the total number of observed malignant
and/or benign brain cancer cases and/or deaths is greater than the number expected based on
standardized comparisons with the general populations of the total U.S., the state of CT and the
local counties from which the workforces are drawn, and to determine whether any observed
excesses are likely to be due to chance factors alone (i.e., are they statistically significant). 3) To
provide a basis for ongoing mortality and cancer incidence surveillance of the P&W CT
workforce.
The cohort will include approximately 263,000 U.S. workers employed since 1952 at one
or more of 8 P&W locations. Those individuals identified as having been diagnosed with brain
or central nervous system will be subjects of the nested case-control study. We anticipate
approximately 7 cases to be identified by the Texas Cancer Registry.
The Connecticut Tumor Registry Program (CTRP) and registries from other states,
including Texas. will be used in the proposed investigation to identify brain cancer cases
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(malignant and benign). The other states will include those in proximity to CT, those where
employees were known to have transferred and those where employees are known to have died,
which includes Texas. A listing of all cohort members, including identifiers, will be submitted to
the TX Cancer Registry; this will then be cross-checked against their files to identify cases of
malignant or benign brain cancer.
To achieve the goals of the nested case-control study, it will be necessary to obtain
detailed information on potential risk factors for brain cancer that is unavailable from existing
record sources. Subjects or their next of kin will be mailed a study packet containing
introductory letters and consent forms. They will be asked to give consent for a telephone
interview, a medical records review, and, for malignant cases only, a genetic evaluation of tumor
tissue.
Using a cohort size of approximately 263,000 and brain cancer case size of
approximately 400, we estimate that our proposed historical cohort study has a greater than 84%
chance of detecting a true 2.0-fold or larger excess in malignant brain cancer among the North
Haven workforce and near certain chance of detecting a true 1.5-fold or greater excess among the
combined study population.
Sara Strom, PhD
University of Texas M.D. Anderson Cancer Center
Data linkage of UTMDACC prostate cancer database with Texas Cancer Registry
IRB #07-057; TCR #07-357; IRB approval 9/23/04
Funding source: multiple National Cancer Institute grants
The overall goal of this data linkage is to verify and supplement clinical data from an
existing study of prostate cancer patients being conducted by the University of Texas M.D.
Anderson Cancer Center (UTMDACC) in Houston, Texas. Since UTMDACC is a tertiary care
center, most patients have been previously diagnosed and/or treated prior to coming to this
institution. Unfortunately, the clinical data regarding stage and date at diagnosis is often missing
from the records submitted to UTMDACC. The information we are requesting from the Texas
Cancer Registry (TCR) would allow us to complete this missing data. No patients will be
identified or recruited from TCR records.
Elaine Symanski, PhD
University of Texas School of Public Health at Houston
Hazardous Air Pollutants and Lymphohematopoietic Cancer Incidence in Houston, 19952005 IRB #07-049; IRB approval 6/4/06; renewal approval
Funding source: National Cancer Institute
The purpose of this study is to investigate the association between air pollution and
lymphohematopoietic cancer incidence in Harris and seven surrounding counties, with particular
emphasis on the roles of benzene, 1,3-butadiene and styrene. We propose analyses of existing
data sets obtained from the Texas Cancer Registry (TCR), 1995-2005, and the Texas
Commission on Environmental Quality (TCEQ), 1992-2003, to address the following aims.
1. To investigate the spatial distribution of lymphohematopoietic cancer incidence in Harris
and surrounding counties.
In a descriptive analysis, Geographic Information Systems (GIS) will be used to map the
incidence of lymphohematopoietic cancer at the census tract level. Spatial autocorrelation
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in incidence rates will be assessed to evaluate the presence of both global and local
clustering. Clustering in time will also be investigated.
2. To test the association between distance from industrial sources and
lymphohematopoietic cancer incidence.
We hypothesize that rates of lymphohematopoietic cancer will be higher in census tracts
surrounding industrial sources compared to those with no sources nearby. A proximity
exposure score will be created based upon the type, location and density of specific
industrial facilities located within or near each census tract. Poisson regression will be
applied to assess whether there is an increase in cancer risk associated with proximity to
industrial sources controlling for occupation, smoking, housing stability, race/ethnicity and
other potential confounders.
3. To evaluate and identify optimal methods for assessing ambient levels of benzene,
styrene and 1,3-butadiene.
Since TCEQ air monitoring sites are not randomly distributed in the study area, we will
utilize spatial interpolation methods (i.e., kriging) to predict pollutant levels for all census
tracts, including those in which no monitors are located. The exposure metric that is
developed using the kriged values will account for disease latency by incorporating lags of
2, 3 and 5 years. A combined exposure score to all three pollutants will also be
constructed.
4. To test the association between estimated ambient levels of benzene, styrene and 1,3butadiene and lymphohematopoietic cancer incidence.
We hypothesize that census tracts with highest ambient levels of benzene, styrene and
1,3-butadiene will have the highest rates of lymphohematopoietic cancer. A Poisson
regression model (using generalized estimating equations (GEE) to account for
correlation of rates within census tracts) will be applied to evaluate the effects of ambient
air pollution (lagged by appropriate intervals to account for disease latency), controlling
for occupation, smoking, housing stability, race/ethnicity and other potential
confounders. Multi-pollutant models will be applied.
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Ongoing studies
Melissa Bondy, PhD
University of Texas M.D. Anderson Cancer Center
Menigioma: Risk factors and Quality of Life
IRB # 06-037; TCR # 07-318; IRB approval 3/15/07; amendment approval 6/29/07
Funding source: National Cancer Institute grant (1401CA10947301A2)
Few studies have examined the risk factors associated with a diagnosis of meningioma,
the most frequently reported of primary intra-cranial neoplasms. At present, the two factors for
which the strongest evidence exists with respect to an association with meningioma risk are
hormones and radiation exposure, however even these factors remain largely unexplored. To
formally and comprehensively examine the environmental, genetic, pathologic and clinical
variables associated with meningioma risk for the first time in a large epidemiological study, we
propose to collect 1600 cases (1000 female and 600 male) and 1600 controls (age-, sex-,
ethnicity- and geography-matched) from five population-based study sites in the states of
Connecticut, Massachusetts, and North Carolina as well as the San Francisco Bay and Houston
areas. Controls will be selected by random-digit-dialing methods by Kreider Research and
Consulting located in Oreno, Maine. Cases will have a histologically or radiologically
confirmed intra-cranial meningioma diagnosed between May 1, 2006 and April 30, 2011; be
residents of the following Houston-area counties: Harris, Fort Bend, Brazoria, Montgomery,
Waller, Chambers, Liberty, and Galveston; be between the ages of 20 to 79 years; and must have
a telephone and be either English or Spanish speaking.
In the Houston area, approximately 400 cases will be accrued in three different ways,
through M.D. Anderson, contacts at outside hospitals, and the Texas Cancer Registry. With the
active consent of each patient’s physician, a trained research interviewer will approach the case
to be consented into the study. If the subject is willing to participate, the patient will be given an
informed consent to sign, as well as an “Authorization for Disclosure of Health Information”
form. A trained phlebotomist will draw 40 ml of blood from the participant. If the patient is
unable or unwilling to provide a blood sample, a saliva sample will be collected using an
ORAGENE kit. Blood or saliva specimens will be collected for testing of DNA polymorphisms
in DNA repair and cell cycle genes. Study participants will also be administered a telephone
questionnaire to collect information on the two primary categories of risk, exposure to ionizing
radiation and hormones as well as additional risk factors such as family history of meningioma
and other tumors, cell-phone utilization, and head trauma as well as questions on outcome and
quality of life. Paraffin-embedded tumor tissue blocks will be obtained on those participants who
had had surgery to allow for a uniform histological review and immunohistochemical testing for
estrogen, progesterone, androgen and MIB-1 receptors.
Melissa Bondy, PhD
University of Texas M.D. Anderson Cancer Center
Molecular and Genetic Epidemiology of Gliomas
IRB # 05-047; IRB approval 11/22/05
Funding source: National Cancer Institute grant (5RO1CA070917-08)
This year 16,800 individuals in the U.S. will be diagnosed with a primary malignant brain
tumor, and 12,000 people will die from these tumors. The heterogeneity of primary brain tumors
and the paucity of large-scale studies of homogeneous tumor types make such determinations
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difficult, as do retrospective assessments of exposures that may have contributed to tumor
development of undefined latency. In a previous study, we found strong preliminary evidence
that patients with brain tumors have poorer DNA repair capacity (as evidenced by a 6-fold
excess risk in mutagen sensitivity) and chromosome instability, using Fluorescence in-situ
hybridization (FISH) techniques, (with a 15-fold risk of spontaneous breaks in cases compared
with controls). Additionally, we found that a small proportion of brain tumors is due to a possible
major “glioma gene” and that the majority of gliomas are sporadic, and most likely due to a
number of high frequency/low penetrance genes. Therefore, we are focusing this study on
identifying genetically susceptible individuals.
We propose a population-based case-control study of 750 newly diagnosed cases of
primary brain tumor (ICD-O-3: C71.0-71.9/ 1910-1919) between the ages of 18 and 74 years.
Controls (N=750), frequency matched to the cases on age, sex, and ethnicity, will be identified
through random digit dialing or the network method. We will identify cases through MD
Anderson and other hospital Radiation Oncology Departments and through the Texas Cancer
Registry. With the physician’s consent, we will contact the patient for consent and then collect a
detailed risk factor and food frequency questionnaire and a blood sample for molecular and
cytogenetic studies to evaluate gene-environment interactions. In addition, we will obtain
medical record information from the patient’s charts and obtain pathology slides/blocks to
confirm the histologic diagnosis to evaluate the risk factors by histologic subtype. Survival data
will also be obtained from the medical records to assess the prognostic predictive value of the
selected markers in brain tumor patients.
Our first aim is to evaluate the hypothesis that diet, occupational exposures, or
nitrosamine exposure may be modulated by susceptibility genes (GSTT1, GSTM1, GSTP1,
CYP2E1, NAT2), as reflected in exposure to nitrosamines and other neurocarcinogens. A
second aim is to assess the role of DNA repair capacity, using two assays that indirectly measure
DNA repair (gamma-induced mutagen sensitivity and FISH), in glioma cases and controls. Our
third aim is to evaluate the frequencies of specific genetic polymorphisms involved in carcinogen
metabolism (GSTM1, GSTT1, GSTP1, NAT2, CYP2E1) and risk of glioma in cases compared
with controls. Our fourth aim is to correlate mutagen sensitivity and chromosome instability
indices with survival outcome and clinical characteristics (such as tumor histology, treatment,
extent of surgery) in the cases.
Ann Coker, PhD
University of Texas School of Public Health at Houston
Air Toxics and Cancer Incidence in Texas
IRB #06-004; TCR #07-268; IRB approval 3/21/06; amendment and renewal approval
3/21/07
The purpose of this project is to determine whether high levels of specific hazardous air
pollutants observed in the immediate areas surrounding the Houston ship channel may be
associated with an increased risk of cancer. According to the EPA, air quality in Houston
reaches unhealthy levels throughout the year but peaks between April and October. One way to
measure the health risks of pollutants is to look at their potential impact on cancer rates.
The current project will consist of an analysis of cancer incidence in the Houston area
and the potential association with poor air quality. A recent environmental study identified
levels of benzene, butadiene and formaldehyde. This exposure data, combined with prevailing
wind patterns will be used to define areas of high to low exposure areas. We will use Dallas/Ft.
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Worth as a comparison city with few industrial areas. Within these geographic areas of various
exposure levels, we will use cancer incidence data from the Texas Cancer Registry to calculate
the population based incidence of cancer type in high, intermediate relative to low exposure
areas. Census data will also be used for demographic differences in population. Multivariate
modeling will be used to estimate relative risk of specific cancers by level of environmental
exposure to estimate the relative risk of specific cancers.
Arthur Shatkin, MD, DrPH
National Cancer Institute
NIH-AARP Diet & Health Study
IRB #06-065; IRB approval 8/30/06; renewal approval 8/29/07
Funding source: National Cancer Institute
This study, which is being conducted by Westat under contract to the National Cancer
Institute (NCI), is designed to prospectively examine the relationship between diet and major
cancers (especially those of the breast, large bowel and prostate) in a sample of early to late
middle-aged men and women in the United States. The study began in 1995. The sampling
frame used for this study was the membership roll of the American Association of Retired
Persons (AARP). The AARP is an ideal source of participants for this study because of the size
and demographics of its membership, and its commitment to promoting the health of its
members.
For this study, participants have been asked to provide three types of health information:
1) dietary history information, 2) cancer risk factor information, and 3) cancer diagnosis
information.
Historically, observational epidemiologic studies of diet and cancer have suffered from
the problem of dietary homogeneity among the study subjects. This study overcomes that
problem by collecting dietary data from a very large number of persons, thereby including those
persons in the extreme categories of dietary intake (in terms of fat, fiber, and other nutrients).
This process ensures that the cohort is heterogeneous in terms of dietary intake.
The primary method of information collection is mail questionnaires. Questionnaires are
formatted for optical scanning which allows very rapid and accurate data entry, editing, and
processing. Cancer information is collected from population-based cancer registries. Vital status
information is collected from Westat’s copy of the latest Social Security Administration (SSA)
mortality database and from the Nation Death Index, a federally operated mortality database.
To collect the dietary data needed for the cohort selection process, a baseline
questionnaire (Primarily a dietary assessment questionnaire) was mailed to 3.5 million AARP
members aged 50 to 69 years sampled from among those who, in 1995, resided in eight states or
metropolitan areas selected for the study. The states and metropolitan areas were selected based
on the quality of the cancer registry, the number of minority residents, and the willingness of the
registry to collaborate with us. The eight states/areas included in the study are: California,
Florida, Louisiana, New Jersey, North Carolina, Pennsylvania, the Detroit metropolitan area and
the Atlanta metropolitan area. Three additional state cancer registries (Texas, Arizona, and
Nevada) were added in 2006 due to participant mobility since 1995.
Following the baseline questionnaire, a second questionnaire was mailed to those persons
who agreed to participate in the study (i.e., who completed and returned the baseline
questionnaire), and who met the study eligibility criteria. The second questionnaire collected
dietary history and additional cancer risk factor information. Dietary and other data collected in
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the two questionnaires indicates that the study cohort of approximately 540,000 persons has a
broad range of dietary intake. The cohort is being followed for outcome assessment in terms of
cancer incidence and mortality. Linkages to mortality databases are performed to learn about
mortality events and linkages to cancer registries are performed to collect outcome (i.e., cancer
incidence) information.
A calibration study was also conducted. The calibration study involved 2,000 study
participants and included 24-hour dietary recall telephone interviews conducted on two separate
occasions with each subject, followed by another mailing of a dietary assessment questionnaire.
The 24-hour dietary recall telephone interview data was compared to the mail questionnaire food
frequency data to measure correlations between the two types of data.
In 2004, an additional component of the study was launched. Collection of bucchal cell
DNA from approximately 90,000 participants in the NIH-AARP Diet and Health Study began.
Collection proceeded according to a case-cohort design; cases comprised all surviving cohort
members diagnosed with colorectal, breast, prostate, or non-Hodgkin’s lymphoma after baseline
(1995-96); the comparison subcohort was randomly selected from the cohort as a whole.
In 2005, a follow-up questionnaire was mailed to participants to obtain information in
daily physical activities; smoking; medication; vitamin and supplement use; family history of
selected cancers, and personal history of cancers, other health conditions, and medical problems.
J.A. Thompson, DVM, DVSc
Texas Vetinary Medical Center
Texas A&M University
Spatial Modeling of Adverse Health outcomes Attributable to Fetal Environmental
Exposures in Texas
IRB #06-032; IRB approval 6/4/06; renewal approval 5/07
Funding source: National Institutes of Health
A number of adverse health outcomes have been attributed to fetal toxic exposures. This
study will identify Texas births from the period of 1990 to 2003 that were associated with
adverse health outcomes. These adverse health outcomes include conditions present at birth and
condition occurring later in life, like childhood cancer. The risks for these adverse outcomes will
be mapped in order to relate the adverse health outcomes to possible environmental toxic
exposures that pregnant women encountered due to their living location.
Guillermo Tortolero-Luna, MD, PhD
Comprehensive Cancer Center, University of Puerto Rico
Analysis of endometrial and ovarian cancer incidence, stage at diagnosis, mortality and
survival by race/ethnicity, area-level socioeconomic status (SES), and rural/urban
residence in Texas, 1995-2002.
IRB #05-029; IRB approval 5/27/05; renewal approval 10/07
Gynecologic malignancies account for approximately 80,000 newly diagnosed cancers
and 29,000 deaths per year in the United States. Endometrial cancer is the most common
gynecological malignancy and ovarian cancer has the highest mortality among cancers of the
female genital tract. Racial/ethnic differences have been noted in both the incidence and the
mortality from these diseases. To data, it is unclear if other socioeconomic variables contribute
to these differences. The purpose of this study is to assess the relationship between incidence,
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stage at diagnosis, mortality and survival from endometrial and ovarian cancer by racial/ethnic
group, area-level SES measures, and rural/urban residence in Texas, 1995-2002.
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