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| Tracking Information | |||||
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| First Received Date ICMJE | November 15, 2007 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00559793 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Levels of Possible Carcinogens From Drinking Water in the Blood and Urine of Healthy Participants After Showering | ||||
| Official Title ICMJE | Levels of Selected Potentially Carcinogenic Drinking Water Disinfection Byproducts in Whole Blood After Showering | ||||
| Brief Summary | RATIONALE: Studying samples of blood and urine in the laboratory from participants exposed to drinking water while showering may help doctors learn more about the way genes are effected by possible carcinogens. PURPOSE: This clinical trial is studying levels of possible carcinogens from drinking water in the blood and urine of healthy participants after showering. |
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| Detailed Description | OBJECTIVES: Primary
OUTLINE: Participants are pre-screened with a normal standard blood panel and for genetic polymorphisms of interest. Participants with enzymes variants of differing activity continue in the study. During the study appointment, participants' blood pressure, height, and weight are measured. Participants also complete a Food and Water Consumption Diary and a Study Check List detailing how much water and food was consumed within the last 48 hours. Participants complete an interview to obtain demographic information (name, address, date of birth, etc.) and information such as sex, height, and weight. Participants are asked about factors, such as exercise, that might affect their breathing. Participants also undergo baseline blood sample collection and provide a urine sample. They will then take a 10-minute shower in a private bathroom at the study site (with water temperature between 104 and 105 degrees) without using soap or shampoo. Blood is collected 10 minutes after the shower and again at 30 minutes after the shower. In order to study the activity of the enzyme, CYP2E1, participants receive a single dose of chlorzoxazone, a muscle relaxant metabolized by the enzyme. Blood is collected 2 hours after chlorzoxazone administration for measurement of enzyme activity. Participants also provide a second urine sample 2 hours after chlorzoxazone administration. Blood is also analyzed for trihalomethanes (THMs). Urine samples are tested for haloacetic acids. Ambient air samples are collected before, during, and after showering (for each participant) and analyzed for THMs. A water sample is collected during the shower and analyzed for levels of THM and haloacetic acids. Levels of THM in blood before and after showering and the rate of decrease in blood concentration is analyzed with respect to the presence of genetic polymorphisms for selected enzymes or their phenotypic activity. Blood THM levels are compared with various demographic and physiologic measurements. In order to test intra-individual variation in several measures, 10 randomly selected participants (stratified by sex [i.e., 5 males and 5 females]) are asked to conduct the study twice. The 2 study appointments are separated by at least 1 week. Left over samples of DNA from previous screening tests at the Center for Clinical Pharmacology are stored for future genetic testing at the National Cancer Institute. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE | Bladder Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00559793 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000566310, NCI-04-C-N228 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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