Heart DiseaseNCT00500734
Cardiomyopathy Tissue Bank in a Cancer Population
An observational study of Heart Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- Blood Sample
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2002to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with heart disease and that may be at a high risk for the development of heart failure.
Who may be able to join
- Patients who are at high risk for developing Cardiomyopathy or Congestive Heart Failure.
- Patients two months of age and older.
Who cannot join
- Those that are not willing to sign an informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jean-Bernard Durand, MD
About this study
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.
Read the 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.
- Conditions
- Heart Disease
- Being tested
- Blood Sample
- Keywords
- Cardiomyopathy, Tissue Bank, Heart Disease, Heart Failure, Congestive Heart Failure
- Medical subject headings
- Heart Diseases, Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleProcedure or surgery
One time blood draw of 2 teaspoons.
| Study group | Role | What they receive |
|---|---|---|
| Heart Disease Patients | Not described Receives: Procedure: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Patient Demographic Information (age, sex, race)
Measured: One time visit.
Identification biological markers predisposing cancer patients to development of chemotherapy-induced congestive heart failure
Measured: One time visit for collection of blood and tissue samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study start10 Dec 2002
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Bernard Durand, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500734
- Sponsor's protocol ID
- ID02-359
- Status last verified
- Jan 2020
- First submitted
- 12 Jul 2007
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiomyopathy Tissue Bank in a Cancer Population
- ClinicalTrials.gov ID
- NCT00500734
- Acronym / sponsor ID
- ID02-359
- Conditions
- Heart Disease
- Keywords
- Cardiomyopathy, Tissue Bank, Heart Disease, Heart Failure, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Dec 2002 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Disease Patients | – | Procedure: Blood Sample |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with heart disease and that may be at a high risk for the development of heart failure.
Key inclusion criteria (2 listed)
- Patients who are at high risk for developing Cardiomyopathy or Congestive Heart Failure.
- Patients two months of age and older.
Key exclusion criteria (1 listed)
- Those that are not willing to sign an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SampleOne time blood draw of 2 teaspoons. | Procedure or surgery | Heart Disease Patients |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Bernard Durand, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Bernard Durand, MD (713-792-6239, jdurand@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Patient Demographic Information (age, sex, race) (time frame: One time visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.