MEDIA AVAILABILITY: NHLBI Awards 12 Women’s Health
Initiative Contracts to Study Genetic and Biological Markers of
Common Diseases Affecting Postmenopausal Women
The Women’s Health Initiative (WHI) embarks on its next phase
of research with 12 new contracts awarded last week by the National
Heart, Lung, and Blood Institute of the National Institutes of Health.
The studies will help explain the postmenopausal hormone therapy
and other clinical trial findings and will investigate the impact
of genetic and biological markers on common diseases affecting postmenopausal
women. The WHI was a major 15-year research program designed to
address the most frequent causes of death, disability and poor quality
of life in postmenopausal women -- cardiovascular disease, cancer,
and osteoporosis.
The new 2-year research projects will apply innovative technologies
to study factors affecting the major diseases in postmenopausal
women. Investigators will conduct their research using blood, DNA
and other biological samples and clinical data from the 161, 808
postmenopausal women who participated in one or more of the three
WHI clinical trials or in the observational study. The total cost
of all of the awards is $18, 679, 000.
The studies, institutions, and principal investigators are (alphabetically
by institution):
- Adipokines and Risk of Obesity-Related Diseases, Albert Einstein
College of Medicine, Bronx, NY, Gloria Ho, Ph.D., M.P.H. The research
team will examine the association of adipokines (physiologically
active proteins from body fat cells) with cancer and stroke risk,
and the role of these proteins in the association between obesity
and the risk of cancer and stroke.
- Physical Activity, Obesity, Inflammation, and CHD in a Multi-Ethnic
Cohort of Women, Brigham and Women’s Hospital and Harvard
Medical School, Boston, MA, I-Min Lee, MBBS, ScD. Dr. Lee and
colleagues seek to clarify the mechanisms underlying the reduced
risk of CHD conferred by physical activity and lower body fat,
beyond their effects on traditional risk factors. Using data from
the WHI Observational Study, the team will examine associations
between physical activity and inflammatory markers and whether
these associations vary by a person’s weight. They will
also look at joint associations between physical activity combined
with weight/obesity status and risk of CHD. The role of inflammatory
markers in mediating the associations of physical activity and
weight with CHD risk will be studied and compared with the role
of traditional risk factors such as blood pressure and cholesterol
levels.
- Endogenous Estradiol and the Effects of Estrogen Therapy on
Major Outcomes of WHI, California Pacific Medical Center, San
Francisco, Steven R Cummings, M.D. The investigators will study
how baseline levels of the estrogen molecule, estradiol, and of
sex hormone binding globulin (SHBG), a protein that binds to testosterone
and estradiol, relate to treatment effects of hormone therapy
on coronary heart disease (CHD), stroke, blood clots, fractures,
breast cancer, dementia, and mild cognitive impairment. The team
will test for interaction of baseline hormone levels with treatment
effects of hormone therapy.
- Identification and Validation of Circulating Biomarkers for
the Early Detection of Breast Cancer in Pre-Clinical Specimens,
Fred Hutchinson Cancer Research Center, Seattle, WA, Christopher
Li, M.D., Ph.D. Using three different proteomics techniques, the
investigators hope to identify proteins associated with breast
cancer as well as biomarkers that could potentially be used for
early detection of breast cancer.
- Proteomics and the Health Effects of Postmenopausal Hormone
Therapy, Fred Hutchinson Cancer Research Center, Seattle, WA,
Ross Prentice, Ph.D. Dr. Prentice and his research team will study
over 1,000 proteins, in order to identify a small number of proteins
potentially associated with CHD, stroke, breast cancer, colon
cancer, or hip fractures in participants in the WHI Observational
Study. Together with other ongoing studies in the hormone trials,
this work may lead to the identification of markers of future
disease, and how these markers relate to the effects of hormone
therapy.
- High-Dimensional Genotype in Relation to Breast Cancer and
WHI Clinical Trial Interventions, Fred Hutchinson Cancer Research
Center, Seattle, WA, Ross Prentice, Ph.D. This genome-wide association
study will examine genetic variations associated with breast tumor
characteristics. Since the studies are being done in women participating
in the hormone therapy, calcium-vitamin D, and low fat diet trials
and the investigators will have access to blood hormone and vitamin
D levels in many of these WHI participants, they hope to explore
biologic pathways by relating treatments, blood levels, and genes
to breast cancer.
- Genome-wide Association Study to Identify Genetic Components
of Hip Fracture, Ohio State University, Columbus, OH, Rebecca
Jackson, M.D. Dr. Jackson and colleagues will seek to identify
common genetic variants that affect the risk for hip fracture
in postmenopausal women participating in the WHI Clinical Trial
and the Observational Study. This will be the first genome-wide
association study of hip fractures. Due to advances in technology,
the entire genome can now be scanned; in the first stage of this
research project, the scientists will study 500,000 genetic variants,
and those that look promising will be specifically investigated
in the two subsequent stages.
- Predictive Value of Nutrient Biomarkers for Coronary Heart Disease
Death, Tufts University, Boston, MA, Alice Lichtenstein, D.Sc.
Dr. Lichtenstein and colleagues will determine the value of selected
nutrient biomarker plasma concentrations (trans fatty acids, very
long chain omega-3 fatty acids, phylloquinone, dihydrophylloquinone)
in women who participated in the WHI Observational Study and died
of CHD. The predictive value of these data relative to self-reported
food intake will also be assessed. The results of this work will
be of value in defining optimal approaches to evaluating the impact
of dietary patterns on CHD risk in large groups of individuals.
- Ancestry Association Analyses of WHI Traits, University of California,
Davis, CA, Michael Seldin, M.D., Ph.D. The investigators will
examine the contribution of ancestry informative markers (AIMS)
in DNA samples to differences in risk of CHD, stroke, breast cancer,
and hip fractures in Blacks and Hispanics. They will also analyze
genetic factors related to ancestry or country of origin affecting
hip fracture and bone mineral density in Whites, and bone mineral
density in Blacks. The results will be a valuable resource to
assist other researchers who wish to combine data of minority
groups with that of Whites.
- Biochemical Antecedents of Fracture in Minority Women, University
of Pittsburgh, Pittsburgh, PA, Jane Cauley, Dr.P.H. This study
will examine risk markers for fracture in groups of minority and
white women. This study will be the first comprehensive investigation
of biochemical factors leading to fracture in minority women.
The results promise to explain differences in fracture rates and
to help target prevention strategies.
- Hormone Therapy, Estrogen Metabolism and Risk of Breast Cancer
or Hip Fracture in the WHI Hormone Trial, University of Pittsburgh,
Pittsburgh, PA, Lewis Kuller, M.D., Dr.P.H. The goal of this study
is to determine whether differences in estrogen metabolism in
untreated women and women on estrogen or estrogen plus progestin
determine risk of hip fracture and breast cancer. The research
team will measure levels of two estrogen metabolites and evaluate
their role as biomarkers of breast cancer and hip fracture. They
will study whether estrogen metabolism differs by whether or not
the estrogen is opposed by a progestin and if how a woman metabolizes
estrogen on hormone therapy relates to the risk of hip fracture.
- Interaction Effects of Genes in the Inflammatory Pathway and
Dietary, Supplement, and Medication Exposures on General Cancer
Risk, Wake Forest University School of Medicine, Winston-Salem,
NC, Jianfeng Xu, M.D., Dr. P.H. The study seeks to identify genetic
variants in genes involved in inflammation and immunity which
are associated with the risk of cancer (breast, colon and rectum,
and lung) in European Americans and African Americans. The research
team will test associations between dietary, supplement and non
steroidal anti-inflammatory use (NSAID) with inflammatory markers
and risk of overall cancer. They will then study interaction effects
of genetic variants with dietary, supplement, and NSAID exposure
on cancer risk.
The NHLBI intends to fund a second round of studies using biological
specimens from the WHI in 2008.
Dr. Jacques Rossouw, WHI project officer, is available to comment
on these awards and the NHLBI’s interest in maximizing the
scientific yield from this landmark study.
To schedule interviews with Dr. Rossouw, contact the NHLBI Communications
Office at 301-496-4236. To interview Dr. Ho, call Karen Gardner,
718-430-3101, Albert Einstein College of Medicine, 718-430-3101;
to interview Dr. I-Min Lee, call Jessica Podlaski, Brigham and Women’s
Hospital, 617-534-1603; to interview Dr. Cummings, call Kevin McCormack,
California Pacific Medical Center, 415-600-2984; to interview Dr.
Li or Dr. Prentice, call Kristen Woodward, Fred Hutchinson Cancer
Research Center, 206-667-5095; to interview Dr. Jackson, call Michelle
Gailiun, Ohio State University Medical Center, 614-293-3737; to
interview Dr. Lichtenstein, call Siobhan Gallagher, Tufts University,
617-636-6586; to interview Dr. Seldin, call Carole Gan, UC –
Davis Health System Public Affairs Office, 916-734-9047; to interview
Dr. Cauley and Dr. Kuller, call Jim Swyers, University of Pittsburgh
Medical Center, 412-586-9773; to interview Dr. Xu, call Karen Richardson,
Wake Forest University Baptist Medical Center, 336-716-4453.
Part of the National Institutes of Health, the National Heart,
Lung, and Blood Institute (NHLBI) plans, conducts, and supports
research related to the causes, prevention, diagnosis, and treatment
of heart, blood vessel, lung, and blood diseases; and sleep disorders.
The Institute also administers national health education campaigns
on women and heart disease, healthy weight for children, and other
topics. NHLBI press releases and other materials are available online
at: www.nhlbi.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and Centers
and is a component of the U. S. Department of Health and Human Services.
It is the primary federal agency for conducting and supporting basic,
clinical, and translational medical research, and it investigates
the causes, treatments, and cures for both common and rare diseases.
For more information about NIH and its programs, visit http://www.nih.gov.
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