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Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods

Primary Purpose

Calibration

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Calibration focused on measuring Buccal Cells, Concordance, DNA Yields, pH Meter, Urine pH, Calibration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Members of the DCEG staff.

Sites / Locations

  • National Cancer Institute (NCI), 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 19, 2006
Last Updated
June 30, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00339443
Brief Title
Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods
Official Title
Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods
Study Type
Observational

2. Study Status

Record Verification Date
May 19, 2010
Overall Recruitment Status
Completed
Study Start Date
November 6, 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 19, 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
We propose to conduct a pilot study among 30 volunteers from the Division of Cancer Epidemiology and Genetics (DCEG) in order to: (1) select the urine pH strip that most closely correlates with urine pH measured by pH meter for the New England Bladder Cancer Study, (2) calibrate the urine pH strip that was used for the Spanish Bladder Cancer Study against pH measured by a pH meter, and (3) compare the DNA yields from buccal cells obtained from two different methods: mouthwash vs toothbrush-rinse method. Information collected from this pilot study will be used to select and optimize the sample collection protocols in the New England Bladder Cancer Study. At the time of enrollment, study participants will be asked to provide information on age, gender, height, weight, consumption of antacids and calcium supplements, and whether they ate, drank or brushed their teeth in the last hour previous to the buccal cells ample collection. In addition, they will have to measure their urine pH with four different pH strips twice a day (early morning and before dinner) for a week and record the measurements in a diary. During the same week, they will be asked to collect two spot urine samples each day from Monday to Thursday (early morning and before dinner), and one more on Friday morning, and bring them into work in a cooler. Also, they will be asked to collect a continuous 24-hour urine sample during one of the three first days of the week. Urine samples will e picked up by lab personnel from BioReliance, and pH will be measured at their laboratory with the four pH strips again and with a pH meter. Buccal cells sample collection will be completed during the first and the last day of the urine sample collection period. The first day, study participants will be asked to provide a water rinse sample after brushing the inside of their cheeks with a toothbrush, and a week later they will be asked to provide a mouth wash sample consisting of two consecutive rinses with Scope mouthwash. All samples and questionnaire data will be unlinked from personal identifiers after the sample collection is completed. Participants will be compensated with $100 for the inconvenience of participating in this complex study and for their time.
Detailed Description
We conducted a pilot study among 30 volunteers from the Division of Cancer Epidemiology and Genetics (DCEG) in order to: (1) select the urine pH strip that most closely correlates with urine pH measured by pH meter for the New England Bladder Cancer Study, (2) calibrate the urine pH strip that was used for the Spanish Bladder Cancer Study against pH measured by a pH meter, and (3) compare the DNA yields from buccal cells obtained from two different methods: mouthwash vs toothbrush-rinse method. At the time of enrollment, study participants were asked to provide information on age, gender, height, weight, consumption of antacids and calcium supplements, and whether they ate, drank or brushed their teeth in the last hour previous to the buccal cells sample collection. In addition, they measured their urine pH with four different pH strips twice a day (early morning and before dinner) for a week and record the measurements in a diary. During the same week, they were asked to collect two spot urine samples each day from Monday to Thursday (early morning and before dinner), and one more on Friday morning, and bring them into work in a cooler. Also, they were asked to collect a continuous 24-hour urine sample during one of the three first days of the week. Urine samples were picked up by lab personnel from BioReliance, and pH was measured at their laboratory with the four pH strips again and with a pH meter. Buccal cells sample collection was completed during the first and the last day of the urine sample collection period. The first day, study participants were asked to provide a water rinse sample after brushing the inside of their cheeks with a toothbrush, and a week later they were asked to provide a mouth wash sample consisting of two consecutive rinses with Scope mouthwash. All samples and questionnaire data was unlinked from personal identifiers after the sample collection was completed. Participants were compensated with $100 for the inconvenience of participating in this complex study and for their time. Information collected from this pilot study has been used to prepare manuscripts, as well as select and optimize the sample collection protocols in the New England Bladder Cancer Study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calibration
Keywords
Buccal Cells, Concordance, DNA Yields, pH Meter, Urine pH, Calibration

7. Study Design

Enrollment
120 (Anticipated)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Members of the DCEG staff.
Facility Information:
Facility Name
National Cancer Institute (NCI), 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods

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