Biological Specimen Collection for Laboratory Methods Development and Training Purposes - Full Text View

Purpose

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 person's 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 1/8-inch long, will be left.

Most participants will be asked to provide only a buccal sample; blood and/or 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.

Condition
Healthy

Study Type:	Observational
Official Title:	Biological Specimen Collection for Laboratory Methods Development and for Training Purposes

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	200
Study Start Date:	October 2001
Estimated Study Completion Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:

All individuals age 21 and older will be eligible.

EXCLUSION CRITERIA:

Participants who have volunteered for previous DCEG studies within the past three years in which buccal or blood samples were collected will be excluded because the samples collected in the current study may be combined with some previously collected samples and duplication of subjects is to be avoided.

Individuals with known active oral disease will be excluded from the buccal cell collection component, and those known to form keloids will be excluded from the skin biopsy component.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025831

Locations

United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Publications:

Buetow KH, Edmonson M, MacDonald R, Clifford R, Yip P, Kelley J, Little DP, Strausberg R, Koester H, Cantor CR, Braun A. High-throughput development and characterization of a genomewide collection of gene-based single nucleotide polymorphism markers by chip-based matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Proc Natl Acad Sci U S A. 2001 Jan 16;98(2):581-4.

ClinicalTrials.gov Identifier:	NCT00025831 History of Changes
Other Study ID Numbers:	020017, 02-C-0017
Study First Received:	October 26, 2001
Last Updated:	March 3, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Buccal
DNA
Pooling
Genotyping

Mouthwash
Healthy Volunteer
HV
Normal Control

ClinicalTrials.gov processed this record on May 19, 2013