NCT00342875

The New England Bladder Cancer Study

Completed Last updated 15 July 2020

What this trial tests

trial in Bladder Cancer in 2,681 participants. Completed in 14 July 2020.

Timeline

1 March 2002

Primary endpoint
16 June 2004

14 July 2020

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,681
Start date	1 March 2002
Primary completion	16 June 2004
Estimated completion	14 July 2020
Sites	1 location across United States

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 30 to 79, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

...

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.