The Framingham Study: Examining DNA Markers and Links to Diseases - Tabular View

Tracking Information
First Received Date ^ICMJE	June 13, 2003
Last Updated Date	August 24, 2009
Start Date ^ICMJE	June 2003
Primary Completion Date	June 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE (submitted: October 19, 2007)	To evaluate the toxicity and efficacy of transfusing selectively depleted donor lymphocytes as part of a nonmyeloablative peripheral blood stem cell transplant in a population of older adults with hematologic malignancies.
Change History	Complete list of historical versions of study NCT00062777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: October 19, 2007)	To define the incidence and severity of acute and chronic GVHD with this approach.

Descriptive Information
Brief Title ^ICMJE	The Framingham Study: Examining DNA Markers and Links to Diseases
Official Title ^ICMJE	A Genome-Wide Scan for Quantitative Trait Loci of Hematocrit - A Framingham Study
Brief Summary	Since 1948, residents of Framingham, Massachusetts, have participated in a program that collects blood samples and clinical data to provide a rare and valuable database for scientific research. The purpose of this study is to support this national resource by aiding in its research capacity. Specifically, researchers in this study will (1) investigate heart, lung, and blood diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel diseases and other health conditions, and (2) examine DNA and its relationship to risk of developing these disease and health conditions. Approximately 330 families have participated in the Framingham Study. Participants will be required to undergo a four-hour exam and to take that exam every two years thereafter. During the exam, the Framingham investigators will (1) interview participants about medical status, health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of medical and hospital records. Participants will also be asked to complete a questionnaire at home regarding dietary and health habits.
Detailed Description	Many studies have shown that hematocrit (HCT) levels are associated with cerebrovascular disease, cardiovascular disease (CVD), peripheral vascular disease, as well as all-cause mortality. Twin studies have shown that HCT variation is largely determined by genetic factors with heritability estimated as 40% - 65%. So far, no linkage analysis in humans between HCT and DNA markers have been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in controlling HCT levels. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in 330 families. HCT was measured in the original cohort and Framingham offspring. These data provide us the opportunity to undertake linkage analyses using variance component method to map quantitative trait loci (QTL) of HCT.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Vascular Diseases
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	330
Completion Date
Primary Completion Date	June 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	INCLUSION /EXCLUSION CRITERIA The study population will include the members of the 330 Framingham Study families with genome scan.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00062777
Responsible Party
Study ID Numbers ^ICMJE	030219, 03-H-0219
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP