Cardiomyopathy Tissue Bank in a Cancer Population

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00500734
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 215.7
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease	Procedure: Blood Sample

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Cardiomyopathy Tissue Bank in a Cancer Population
• Actual Study Start Date: Dec 10, 2002
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Heart Disease Patients	Procedure: Blood Sample; One time blood draw of 2 teaspoons.

Outcome Measures

Primary Outcome Measures

1. Baseline Patient Demographic Information (age, sex, race) [One time visit.]

2. Identification biological markers predisposing cancer patients to development of chemotherapy-induced congestive heart failure [One time visit for collection of blood and tissue samples.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Jean-Bernard Durand, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00500734
• Other Study ID Numbers: ID02-359
• First Posted: Jul 13, 2007
• Last Update Posted: Jan 27, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by M.D. Anderson Cancer Center: Cardiomyopathy; Tissue Bank; Heart Disease; Heart Failure; Congestive Heart Failure
• Additional relevant MeSH terms: Heart Diseases; Cardiomyopathies

Study Results

No Results Posted as of Jan 27, 2020