NCT00500734

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2002

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

18 years

First QC Date

July 12, 2007

Last Update Submit

January 24, 2020

Conditions

Keywords

CardiomyopathyTissue BankHeart DiseaseHeart FailureCongestive Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Baseline Patient Demographic Information (age, sex, race)

    One time visit.

  • Identification biological markers predisposing cancer patients to development of chemotherapy-induced congestive heart failure

    One time visit for collection of blood and tissue samples.

Study Arms (1)

Heart Disease Patients

Procedure: Blood Sample

Interventions

Blood SamplePROCEDURE

One time blood draw of 2 teaspoons.

Heart Disease Patients

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Those that are not willing to sign an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Heart DiseasesCardiomyopathiesHeart Failure

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-Bernard Durand, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Bernard Durand, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

December 10, 2002

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations