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The New England Bladder Cancer Study

30 Years
79 Years
Not Enrolling
Bladder Cancer

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Trial Information

The New England Bladder Cancer Study

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

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.


Children will be excluded from this study.

Type of Study:


Study Design:


Principal Investigator

Dalsu Baris, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

February 2002

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Case-Control Study
  • Environment
  • Arsenic
  • Drinking Water
  • Exposure
  • Bladder Cancer
  • Urinary Bladder Neoplasms



National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland  20892