Additional Clinical Trials Resources
Cancer Clinical Trials at NIH
NCI supports cancer clinical trials across the country (U.S) through
its extramural research program. Meanwhile, on NIH’s main campus, the
Institute’s intramural researchers in the
Center for Cancer Research (CCR)
conduct hundreds of trials each year at the NIH Clinical Center in
Bethesda, MD, and these trials often differ from those available
elsewhere.
While some cancer centers also offer early-stage clinical
trials, the difference is that CCR focuses almost exclusively on
early-stage trials, said Dr. Bill Dahut, CCR’s clinical director.
NCI’s intramural program is able to pay the transportation
costs for patients who are enrolled in Clinical Center trials. This
allows CCR to see many more patients with rare cancers, or rare subtypes
of common cancers, than other research sites because CCR can fly in
patients from around the country to be treated in investigational
studies.
One commonly cited barrier to entering clinical trials is the
worry among both patients and their physicians of losing control. “An
important point about treatment at NCI is that everything we do here for
patients is done in close collaboration with their local physicians
back home,” Dr. Dahut explained. “Our physicians provide expert clinical
care to patients while they are being treated on protocol at NCI, but
our physicians can see patients only while they are at the Clinical
Center. Thus, continued care by local physicians is incredibly important
to allow patients to access standard treatments or other trials not
available here. Local physicians must remain closely involved with
patients on NCI studies because side effects, from the cancer or the
therapy, may occur when the patient is home and far from Bethesda.”
Patients and physicians interested in exploring cancer clinical
trials at NIH can visit
CCR’s
clinical trials Web site. The site includes detailed descriptions
of clinical trials currently recruiting patients; information for the
general public about clinical trials and participating in trials at NCI;
and information for health professionals about referring patients, the
Center’s clinical programs and investigators, and ways to keep up to
date with CCR research and opportunities.
“We’d really like to encourage physicians to join our
mailing
list,” said Susan McMullen, patient outreach and recruitment
coordinator for CCR’s Office of the Clinical Director. “One of the
barriers to recruiting patients at NIH is that our doctors don’t have a
patient base outside of clinical trials to draw from, so we rely on
community doctors to refer patients to us.”
Family Cancer Registries
For some families, the tragedy and sorrow of losing a relative
to cancer is repeated as family member after family member is diagnosed
with the same disease.
To determine what genetic factors may be at work
and how environmental influences alter those genetic risks, researchers
rely on those affected by
familial cancer
to participate in family cancer registries.
“Our major goal in studying these families is to identify what
are called high-risk susceptibility genes,” explained Dr. Peggy Tucker,
director of the
Human
Genetics Program and chief of the
Genetic Epidemiology Branch in
NCI’s Division of Cancer Epidemiology and Genetics (DCEG). “We then try
to understand the function of those genes, how they confer risk, and
what other factors within the family modify risk.
“Ultimately, we want to be able to alter the risk of cancer in
these families either by identifying susceptibility factors we can
modify—for example, avoiding sun exposure in melanoma families—or
designing interventions that can affect risk—such as
prophylactic
oophorectomy for women in families with high risk of both breast and
ovarian cancer,” she said.
Family cancer registry studies can also help inform researchers
about cancer
susceptibility
risks in the general population. For example, researchers
identified
dysplastic
nevi as a major risk factor for melanoma by studying families at
high risk of melanoma.
Researchers at NCI first began conducting family registry
studies in the mid-1960s. These long-term studies follow families
through successive generations, and allow researchers to examine the
role of inherited high-susceptibility genes and cancer. Today, DCEG
researchers are
studying
families with a number of inherited cancers or
cancer-susceptibility syndromes, and researchers in NCI’s Division of
Cancer Control and Population Sciences (DCCPS) sponsor the
Breast and Colon Cancer Family
Registries.
Whereas DCEG’s family registries are conducted at the NIH
Clinical Center, the family registries based in DCCPS are found
throughout the United States, Australia, and Canada. “Currently, we have
about 78,000 men and women from nearly 26,000 families participating in
these registries,” said Dr. Sheri Schully, program officer for the
DCCPS family registries program. “The main objective of these registries
is to identify and characterize cancer susceptibility genes, but the
investigators also look at gene–gene and gene–environment interactions
as well.”
Although family registry studies do not provide treatment to
participating families, investigators often provide test results that
can help family members learn which of them may be at higher risk
because of certain susceptibility genes, such as mutations in the
BRCA1 and
BRCA2
genes or those associated with
Lynch syndrome,
said Dr. Schully.
Additionally, the studies are an opportunity for people who are
often desperate for answers to ask questions.
“We like to think it’s a positive experience for them because
they have a whole day at NIH to meet with physicians and nurses who know
a lot about the disease,” Dr. Tucker explained. “We try to keep them
updated with new findings about the diagnosis and management of the
cancer that affects their family, and they know they can always come to
us for referrals for care of the disorders that we’re studying.”
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