Cardiomyopathy Tissue Bank in a Cancer Population - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00500734

Purpose

The purpose of this research is to collect blood and tissue for DNA and biomarkers and store for future analysis. This will be done in patients predisposed to cardiomyopathy and congestive heart failure, and its complications, i.e., sudden cardiac death, pump failure and ventricular arrhythmia. There are currently no known genetic markers which predispose to congestive heart failure. The samples will be stored for future use in analysis of molecular, cellular and biological characteristics approved by the IRB. A database of these samples will be developed and samples will be coded in laboratory and storage and only through specific access code, samples will be linked to specific patients. This will be done to maintain patient confidentiality. Additional protocols are to be submitted to the IRB committee in future analysis of stored tissue/DNA/serum stored and used in the future.

Condition	Intervention
Heart Disease	Procedure: Blood Sample

MedlinePlus related topics: Cancer Cardiomyopathy Heart Diseases Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Cardiomyopathy Tissue Bank in a Cancer Population

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To collect and store blood and tissue from patients who have a diagnosis of heart disease and may be at a high risk for the development of heart failure. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood and tissue collection. This blood may be studied in the future to try to find possible genetic or biochemical markers that may be the cause of CHF.

Estimated Enrollment:	1000
Study Start Date:	December 2002
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients diagnosed with heart disease and that may be at a high risk for the development of heart failure.	Procedure: Blood Sample One time blood draw of 2 teaspoons.

Detailed Description:

You will have a one time blood draw of 2 teaspoons of blood for use in future research. This blood may be studied in the future to try to find possible genetic or biochemical markers that may be the cause of CHF. Your blood will be drawn either on an outpatient basis or during a routine visit to the hospital. If you already have a central line or an IV placed, the blood will be drawn at these sites to decrease the pain and discomfort of the blood draw. The information obtained in this study will not be put into your medical records.

This is an investigational study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	2 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with heart disease and that may be at a high risk for the development of heart failure.

Criteria

Inclusion Criteria:

Patients who are at high risk for developing Cardiomyopathy or Congestive Heart Failure.
Patients two months of age and older.

Exclusion Criteria:

Those that are not willing to sign an informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500734

Contacts

Contact: Jean-Bernard Durand, MD

713-792-6239

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jean-Bernard Durand, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Jean-Bernard Durand, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Jean-Bernard Durand, MD/Assistant Professor )
Study ID Numbers:	ID02-359
Study First Received:	July 12, 2007
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00500734
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cardiomyopathy
Tissue Bank
Heart Disease
Heart Failure
Congestive Heart Failure

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009