Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025831
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-10-26
Brief Title:
Biological Specimen Collection for Laboratory Methods Development and Training Purposes
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biological Specimen Collection for Laboratory Methods Development and for Training Purposes
Status:
COMPLETED
Status Verified Date:
2005-09
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:
This study will collect biological samples-buccal cells blood sample skin sample-to be used in developing and testing laboratory methods for measuring and analyzing genes Such methods can be used for research on identifying genetic factors that may affect a persons cancer risk
All individuals age 21 and older may participate in this study Participants will provide one or more of the following samples
Buccal mouth cells - obtained by swishing a small amount of mouthwash in the mouth or by swabbing or bushing the inside of the cheek with a swab or brush
Blood - obtained by pricking the finger and collecting the drops or by blood drawing through a needle placed in an arm vein
Skin - obtained by a punch biopsy on the inner upper arm For this procedure the skin is anesthetized and a small piece of skin is removed with a sharp instrument similar to a cookie cutter The wound is then covered and held together with a sterile bandage A small scar approximately 18-inch long will be left
Most participants will be asked to provide only a buccal sample blood andor skin samples will be requested from a few participants The blood and skin samples may be used to grow cell lines that is to make them grow indefinitely for research uses
All individuals age 21 and older may participate in this study Participants will provide one or more of the following samples
Buccal mouth cells - obtained by swishing a small amount of mouthwash in the mouth or by swabbing or bushing the inside of the cheek with a swab or brush
Blood - obtained by pricking the finger and collecting the drops or by blood drawing through a needle placed in an arm vein
Skin - obtained by a punch biopsy on the inner upper arm For this procedure the skin is anesthetized and a small piece of skin is removed with a sharp instrument similar to a cookie cutter The wound is then covered and held together with a sterile bandage A small scar approximately 18-inch long will be left
Most participants will be asked to provide only a buccal sample blood andor skin samples will be requested from a few participants The blood and skin samples may be used to grow cell lines that is to make them grow indefinitely for research uses
Detailed Description:
We propose two related activities that involve the collection of biological samples The first involves the collection of mouthwash samples from 200 volunteers to assess the feasibility of pooling samples for quantitative genotype determinations For a small number of volunteers we will also collect a peripheral blood sample and a skin punch biopsy for establishment of lymphoblastoid and fibroblast cell lines The blood and skin samples will be used to compare the amount and subcellular localization of DNA repair proteins between lymphocytes cells most commonly collected in epidemiologic studies and fibroblasts the cell types commonly used in assay development In addition we will conduct hands-on education and training sessions in molecular genetics for members of DCEG and others The hands-on education sessions will be aimed at non-laboratory scientists and involve 6-9 hours of demonstration and participation in basic molecular genetics techniques Participants will have the option of collecting their own mouthwash sample extracting the DNA and performing a genotyping assay on their sample in the Laboratory of Population Genetics in Building 41 After the education session the biological samples will be reassigned arbitrary numbers not linked to personally identifying information and will be used for laboratory methods development only
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-0017 | None | None | None |