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Cardiomyopathy Tissue Bank in a Cancer Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00500734
Recruitment Status : Recruiting
First Posted : July 13, 2007
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date July 12, 2007
First Posted Date July 13, 2007
Last Update Posted Date January 27, 2020
Actual Study Start Date December 10, 2002
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2009)
  • Baseline Patient Demographic Information (age, sex, race) [ Time Frame: One time visit. ]
  • Identification biological markers predisposing cancer patients to development of chemotherapy-induced congestive heart failure [ Time Frame: One time visit for collection of blood and tissue samples. ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiomyopathy Tissue Bank in a Cancer Population
Official Title Cardiomyopathy Tissue Bank in a Cancer Population
Brief Summary

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this laboratory research study is 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. This blood may be used in the future to identify genes that may play a role in developing congestive heart failure (CHF) from chemotherapy or other sources.

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

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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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.
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.
Condition Heart Disease
Intervention Procedure: Blood Sample
One time blood draw of 2 teaspoons.
Study Groups/Cohorts Heart Disease Patients
Intervention: Procedure: Blood Sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 12, 2007)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jean-Bernard Durand, MD 713-792-6239 jdurand@mdanderson.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00500734
Other Study ID Numbers ID02-359
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Jean-Bernard Durand, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date January 2020