Bladder CancerNCT00011518
Bladder Cancer Case Control Study of Arsenic in Water
An observational study of Bladder Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
This study is examining the relationship between ingested arsenic and bladder cancer in two areas of California where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1997to Jul 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Cases must meet the following criteria:
- Diagnosed with primary bladder cancer from January 1, 1997 until December 31, 2000.
- Live in the following counties at the time of diagnosis: Churchill, Lyon, Mineral, Storey, Douglas, Carson City, Nevada, and Kings County, California
- Ages 20-85 at the time of diagnosis.
Controls will be matched to cases based on gender and five year age groups.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allan Smith Research Office
Berkeley, California, 94720
About this study
This study is examining the relationship between ingested arsenic and bladder cancer in two areas of California where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels.
Read the detailed description
Water supplies in many parts of the world contain naturally occurring arsenic. Previous studies have shown that arsenic at high doses can cause cancer of the bladder. The risk at lower doses is unknown. This study is examining the relationship between ingested arsenic and bladder cancer in central Nevada and Kings County, California, two areas where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels. Approximately 200 people with bladder cancer and 400 people without bladder cancer will be included. Subjects are interviewed by telephone about past residences, occupations, diet, drinking water consumption, and other lifestyle factors. Arsenic measurements in well water have been collected from the appropriate state agencies and are being matched with residences and drinking water consumption rates to estimate lifetime arsenic exposures for each subject. People with bladder cancer will then be compared to those without to see if people with cancer were more likely to have lived in areas with arsenic in their drinking water.
- Conditions
- Bladder Cancer
- Keywords
- Arsenic, Bladder Cancer, Drinking Water
- Medical subject headings
- Urinary Bladder Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2001 (estimated)
- Study startOct 1997
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011518
- Sponsor's protocol ID
- 7459-CP-001
- Status last verified
- Mar 2006
- First submitted
- 22 Feb 2001
- Last updated
- 23 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Cancer Case Control Study of Arsenic in Water
- ClinicalTrials.gov ID
- NCT00011518
- Acronym / sponsor ID
- 7459-CP-001
- Conditions
- Bladder Cancer
- Keywords
- Arsenic, Bladder Cancer, Drinking Water
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Oct 1997
- Study completion
- Jul 2001
- First posted
- 26 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is examining the relationship between ingested arsenic and bladder cancer in two areas of California where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels.
Detailed description
Water supplies in many parts of the world contain naturally occurring arsenic. Previous studies have shown that arsenic at high doses can cause cancer of the bladder. The risk at lower doses is unknown. This study is examining the relationship between ingested arsenic and bladder cancer in central Nevada and Kings County, California, two areas where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels. Approximately 200 people with bladder cancer and 400 people without bladder cancer will be included. Subjects are interviewed by telephone about past residences, occupations, diet, drinking water consumption, and other lifestyle factors. Arsenic measurements in well water have been collected from the appropriate state agencies and are being matched with residences and drinking water consumption rates to estimate lifetime arsenic exposures for each subject. People with bladder cancer will then be compared to those without to see if people with cancer were more likely to have lived in areas with arsenic in their drinking water.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2006.