- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135849
B-Receptor Signaling in Cardiomyopathy
Study Overview
Status
Conditions
- Soft Tissue Sarcoma
- Lymphoma, Non-Hodgkin
- Leukemia
- Breast Cancer
- Myeloproliferative Disorders
- Multiple Myeloma
- Anemia
- Pancreatic Cancer
- Hodgkin Disease
- Esophageal Cancer
- Amyloidosis
- Lung Cancer
- Bone Cancer
- Prostate Cancer
- Neuroendocrine Tumors
- Mesothelioma
- Skin Cancer
- Thyroid Cancer
- Anal Cancer
- Hepatobiliary Neoplasm
- Transitional Cell Carcinoma of Bladder
- Gastrooesophageal Cancer
- Myelodysplastic Syndromes (MDS)
- Cancer of Brain and Nervous System
- Gall Bladder Cancer
- Head and Neck Cancers
- Testicular Cancer
- Thymus Cancer
- Gastrointestinal Stromal Tumor (GIST)
- Carcinomas
- Bone Marrow Transplant Failure
- Cholangiocarcinoma of the Extrahepatic Bile Duct
- Eye Cancer
- Carcinoma of the Large Intestine
- Endocrine Cancer
- Gastric (Stomach) Cancer
- Gynecologic Cancers
- Kidney (Renal Cell) Cancer
Detailed Description
There is a strong correlation between total doxorubicin dose and anti-tumor efficacy, however, the clinical utility of doxorubicin is severely limited by its cardiotoxicity. With improved methods of detecting subtle changes in cardiac function, e.g. alterations in left ventricular wall stress (1), the incidence of doxorubicin cardiotoxicity is now appreciated to be much higher than previously suspected, documented in 65% of long-term survivors of childhood cancer, even at doses as low as 228 mg/m2. This cardiotoxicity is dose-related, and higher doses are related to a higher incidence of clinical heart failure (2). Doxorubicin's cardiotoxicity is thought to be mediated through the generation of free radicals and through mitochondrial and membrane damage.
We wish to determine whether beta-receptor genotype affects anthracycline-induced cardiomyopathy. We will correlate beta-receptor genotype with difference in wall stress post-anthracycline exposure, and with difference in shortening fraction. We plan to recruit 300 patients over a two-year period. Inclusion criteria includes past exposure to anthracycline for cancer treatment and an echocardiogram 6 - 48 months after exposure to anthracyclines.
The mean difference in 1.) wall stress and 2.) shortening fraction between each minor allele subgroup and wild type subgroup, for both beta-1 and beta-2 will be assessed using unpaired t-test analyses . We will assess through multivariate linear regression whether there are interactions between differences in wall stress or fractional shortening and other variables such as age, gender, dose of anthracycline, type of anthracycline given, and time between anthracycline exposure and echocardiogram. Those who receive other cardiotoxic drugs (such as trastuzumab for breast cancer) will be analyzed separately.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:1.) Past exposure to anthracycline chemotherapy for cancer
2.) Echocardiogram at least six months after exposure to anthracyclines (in patients over the age of 40, the echocardiogram must be obtained within 6 - 48 months of anthracycline exposure)
3.) Ability to understand and the willingness to sign a written informed consent document.
We have no age, gender, or ethnic background limitations. Due to the increased frequency of cardiovascular disease from other causes in adults over 40 years, we will limit enrollment to those patients with an echocardiogram 6 - 48 months after the completion of anthracycline exposure. Children will be included and will be eligible if they have an echocardiogram at least 6 months after completion of anthracycline treatment..
Exclusion Criteria:1.) Congenital heart disease (other than patent foramen ovale)
2.) Pre-existing cardiomyopathy before anthracycline administration
3.) Patients with Down syndrome
4.) Patients receiving B-blocker therapy at the time of anthracycline exposure
5.) Pregnant patients (if their echocardiogram was obtained either during pregnancy or within three months of pregnancy)
All participants will be cancer survivors. To minimize bias from post-partum cardiomyopathy, pregnant patients will be excluded if their echocardiogram was obtained during pregnancy or within three months of pregnancy. HIV-positive persons will not be excluded from the study.
Of note, some patients receive a MUGA (multigated acquisition) study to evaluate left ventricular ejection fraction. Patients who receive only a MUGA scan will NOT be included in the study - an echocardiogram is necessary
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of cardiomyopathy
Time Frame: Within 5 years after receiving anthracyclines.
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Decrease in fractional shortening below normal (<28%)
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Within 5 years after receiving anthracyclines.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Bernstein, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Urinary Bladder Diseases
- Endocrine System Diseases
- Gonadal Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Genital Neoplasms, Male
- Testicular Diseases
- Hemorrhagic Disorders
- Musculoskeletal Diseases
- Thoracic Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Intestinal Diseases
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Intestinal Neoplasms
- Rectal Diseases
- Proteostasis Deficiencies
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Bone Diseases
- Neoplasms, Plasma Cell
- Colorectal Neoplasms
- Precancerous Conditions
- Gallbladder Diseases
- Biliary Tract Diseases
- Neoplasms, Connective Tissue
- Lymphoma
- Adenoma
- Neoplasms, Mesothelial
- Rectal Neoplasms
- Anus Diseases
- Biliary Tract Neoplasms
- Sarcoma
- Carcinoma, Renal Cell
- Myelodysplastic Syndromes
- Stomach Neoplasms
- Testicular Neoplasms
- Carcinoma
- Multiple Myeloma
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Amyloidosis
- Thymus Neoplasms
- Preleukemia
- Bone Neoplasms
- Urinary Bladder Neoplasms
- Brain Neoplasms
- Gastrointestinal Stromal Tumors
- Cardiomyopathies
- Cholangiocarcinoma
- Carcinoma, Transitional Cell
- Neuroendocrine Tumors
- Mesothelioma
- Myeloproliferative Disorders
- Anus Neoplasms
- Endocrine Gland Neoplasms
- Gallbladder Neoplasms
- Eye Neoplasms
Other Study ID Numbers
- PEDSVAR0038
- SU-11172008-1345 (Other Identifier: Stanford University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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