Ascertainment of Saliva or Blood Samples For Genetic Epidemiology Studies of Cancer and Aging

This study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, June 2009

First Received: December 20, 2007 Last Updated: June 19, 2009 History of Changes

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Susan G. Komen Breast Cancer Foundation Beth Abraham Gurwin Jewish Geriatric Center Hebrew Home for the Aged Jewish Home and Hospital Lifecare System Margaret Tietz Center Metropolitan Jewish Health System Northern Services Group Parker Jewish Institute Lenox Hills Senior Center JASA at Temple Emanuel of Parkchester Senior Center Van Cortlandt Village Senior Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00579618

Purpose

The purpose of this study is to help us learn more about the roles of genes in cancers. Genes are short pieces of DNA which determine the inherited characteristics that distinguish one individual from another. This study will look at how some genes might raise or lower the chance some people may develop cancer. The sample collection will help generate the materials needed for this study.

Condition	Intervention
Non-Cancer Affected Volunteers	Other: Saliva or Blood samples

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	Ascertainment of Saliva or Blood Samples For Genetic Epidemiology Studies of Cancer and Aging

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

obtain saliva or blood from non-cancer volunteers self-identified as being of Ashkenazi Jewish ancestry, 60 years or older & residing in select nursing homes, to carry out anonymous genetic epidemiology studies related to resistance to cancer in elderly. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

samples perform high density genomic scans & candid gene studies carriers specif BRCA found mutat who haven't been affect by breast cancer & old than 60 find genetic cofactor may modify a predispo breast ca confer by germline mutation in BRCA1 & BRCA2. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	3000
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Extracting sample of saliva or blood only once.

Detailed Description:

This is a protocol to obtain saliva or blood samples from non-cancer affected volunteers selfidentified as being of Ashkenazi Jewish ancestry, aged 60 years or older, without a history of cancer other than non-melanoma skin cancer and residing in selected nursing homes in the New York City area. These samples will be used in a genomic approach to elucidate novel pathways that modify BRCA penetrance.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Eligible subjects must be non-cancer affected volunteers of either gender who are 60 years of age or older at the time of saliva/blood donation.
Subjects will self-identify as being of Jewish religion with four grandparents of eastern European origin.
Volunteers will have (by self report) no history of cancer other than nonmelanoma skin cancer. It is recognized that there may be some errors in self report, however, the literature reports a very low error rate for self reported disease reporting for cancer as assessed by interview.

Exclusion Criteria:

Subjects not able to give informed consent due to mental impairment will be excluded unless authorized by their power of attorney.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579618

Contacts

Contact: Kenneth Offit, MD

offitk@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Kenneth Offit, MD offitk@mskcc.org
Principal Investigator: Kenneth Offit, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Susan G. Komen Breast Cancer Foundation

Beth Abraham

Gurwin Jewish Geriatric Center

Hebrew Home for the Aged

Jewish Home and Hospital Lifecare System

Margaret Tietz Center

Metropolitan Jewish Health System

Northern Services Group

Parker Jewish Institute

Lenox Hills Senior Center

JASA at Temple Emanuel of Parkchester Senior Center

Van Cortlandt Village Senior Center

Investigators

Principal Investigator:

Kenneth Offit, MD, MPH

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Kenneth Offit, MD )
Study ID Numbers:	06-102
Study First Received:	December 20, 2007
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00579618 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

non-cancer affected volunteers
Ashkenazi Jewish ancestry
aged 60 years or older

ClinicalTrials.gov processed this record on September 10, 2009