Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339443
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
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
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-05-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-N040 | None | None | None |