A Genome-Wide Scan For Quantitative Trait Loci of Serum Bilirubin - A Framingham Study - Tabular View

Tracking Information
First Received Date ^ICMJE	June 19, 2006
Last Updated Date	September 12, 2009
Start Date ^ICMJE	October 2001
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE (submitted: October 19, 2007)	To determine the maximum tolerated dose (MTD) and recommended phase II dose of CC-5013 (lenalidomide) administered orally once daily for 21 days, followed by a 1 week rest to children with refractory solid tumors.
Change History	Complete list of historical versions of study NCT00340509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: October 19, 2007)	To define preliminarily the antitumor activity of CC-5013 within the confines of a phase I study.

Descriptive Information
Brief Title ^ICMJE	A Genome-Wide Scan For Quantitative Trait Loci of Serum Bilirubin - A Framingham Study
Official Title ^ICMJE	A Genome-Wide Scan For Quantitative Trait Loci of Serum Bilirubin - A Framingham Study
Brief Summary	Studies have shown that there is a significant association between serum bilirubin concentrations and risk of coronary artery disease (CAD). So far, no linkage analysis in humans between serum bilirubin and DNA markers has been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in serum bilirubin metabolism and bilirubin concentration. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in more than three hundred families. Serum bilirubin was measured in the first and second exams of the Framingham Offspring. These data provide us the opportunity to undertake linkage analyses to map QTL of serum bilirubin.
Detailed Description	Many studies showed that there is a significant relationship between serum bilirubin levels and risk of coronary artery disease (CAD). We carried out a genome-wide scan for quantitative trait loci of serum bilirubin through the 330 extended Framingham families and found significant evidence of linkage of serum bilirubin to chromosome 2q telomere where an important candidate gene, Uridine diphosphate glycosyltransferase 1 gene (UGT1A1), resides. The purposes of this protocol are to confirm linkage between serum bilirubin and UGT1A1, mathematical modeling and association studies between the genotypes of UGT1A1 and CAD.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Genetics
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	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA: The study population will include the members of the 330 Framingham Study families with genome scan. The Original Cohort will also be included.
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	NCT00340509
Responsible Party
Study ID Numbers ^ICMJE	999902016, 02-H-N016
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	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP