The New England Bladder Cancer Study



Status:Completed
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:30 - 79
Updated:2/17/2019
Start Date:February 27, 2002

Use our guide to learn which trials are right for you!

Data from the new cancer atlas covering the period 1974 1994 indicates that deaths from
bladder cancer among white men and women are elevated in the northeastern United States,
particularly the northern parts of New England. The reason for these elevated rates of
incidence of and deaths from bladder cancer is unknown. Only part of the excess risk can be
explained by exposure to the textile and leather industries.

The purpose of this study is to determine the factors that contribute to the high rates of
incidence of and death from bladder cancer in northern New England. The main objectives are
to:

- estimate the risk of developing bladder cancer associated with inorganic arsenic in
drinking water, other water contaminants, tobacco use, occupational exposures,
residential proximity to industrial sites, dietary factors, ethnicity, and use of
wood-burning stoves.

- estimate the extent to which water containing inorganic arsenic explains the increased
rates of bladder cancer.

- estimate the extent to which exposure to other risk factors explains the increased
rates.

- evaluate risk of bladder cancer according to genetic factors.

- examine interactions of these factors with tobacco use, occupational exposure, and
environmental exposure to arsenic and other compounds.

All people ages 30 79 with confirmed cases of bladder cancer will be eligible for the study.
Twelve hundred people with bladder cancer and twelve hundred individuals with no previous
bladder cancer will be included.

After potential participants are recruited and agreement is obtained over the telephone, they
will complete a calendar and collect toenail clippings prior to the home interview. During
the home visit, an investigator will administer a computer-assisted personal interview,
collect drinking water samples and the clippings, and obtain a global positioning satellite
reading. Other biological samples, such as saliva samples, urine, and blood, may be
requested.

Private wells at any previous homes of participants will also be sampled. The location of
previous homes will be determined and the current homeowner will be asked to allow sampling
of the well.

The associations between bladder cancer and environmental exposures will be examined and the
extent to which exposures to such risk factors explain the elevated mortality and incidence
in northern New England will be estimated.

Data from the new cancer atlas covering the period 1970-94 indicate that bladder cancer
mortality rates among white men and women are elevated in the northeastern U.S., particularly
in the northern parts of New England including Maine, New Hampshire, and Vermont. The reasons
for these high mortality rates are unclear. The persistent elevations in mortality and
incidence for bladder cancer among both men and women suggest the possible role of
environmental etiologic factors. A leading suspect environmental exposure is inorganic
arsenic in drinking water, which is elevated in private wells in parts of New England. The
purpose of this study is to determine the risk factors that explain the high mortality and
incidence rates for bladder cancer in men and women in northern New England. The study will
be a population-based case-control study of carcinoma of the urinary bladder in three states:
New Hampshire, Vermont, and Maine. All histologically-confirmed incident cases of carcinoma
of the bladder occurring within a three-year period among residents of the study areas
between the ages of 30 and 79 years will be eligible for the study. Controls will be selected
randomly from the general population of each study area, frequency matched to the age-,
race-, and gender-specific distributions of incidence cases of bladder cancer in each state.
We expect to interview 1,200 cases and 1,200 controls. Several data collection activities
will be incorporated in this study: a self-administered residential/occupational history
calendar, a self-administered diet questionnaire, in-person interviews with subjects using a
computer-assisted personal interview (CAPI), collection of drinking water to determine levels
of arsenic and other contaminants in drinking water, a collection of buccal cells, toenails,
spot urine, four-day urinary habits diary, overnight urine (from a sample of 240 cases and
240 controls), and blood (from a sample of 180 cases and 180 controls). Tumor tissue samples
will be obtained for cases. We will examine associations between bladder cancer and
environmental exposures, and estimate the extent to which exposures to such risk factor
explain the elevated mortality and incidence in northern New England.

- INCLUSION CRITERIA:

All histologically-confirmed incident cases of carcinoma of the bladder, including
carcinoma in situ, between the ages of 30 and 79 years occurring among residents of New
Hampshire, Maine and Vermont during an accrual period of about three years are eligible to
be included in the study.

Controls must be aged 30 to 79, with no previous bladder cancer diagnosis. Individuals with
other malignancies will not be excluded.

Controls under age 65 will be selected among residents of the three states with valid
driving license from the Motor Vehicle Administration (MVA) computer tapes at six-month
intervals.

Controls aged 65 to 79 will be identified from the Centers for Medicare and Medicaid
Services (CMS) files.

CMS controls will be selected at six-month intervals over the interviewing period of the
study from the most recently available updated tapes.

EXCLUSION CRITERIA:

Children will be excluded from this study.
We found this trial at
1
site
9609 Medical Center Drive
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute , 9000 Rockville Pike The National Cancer Institute (NCI) is part of...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials