Clinical Trials Logo

Clinical Trial Summary

We hope to determine the importance of different genes (including B receptors) in anthracycline-induced cardiomyopathy. This has important benefits to patients exposed to anthracyclines, as this could help determine whether certain individuals have increased susceptibility to cardiac injury.


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Amyloidosis
  • Anal Cancer
  • Anemia
  • Bone Cancer
  • Bone Marrow Transplant Failure
  • Brain Neoplasms
  • Breast Cancer
  • Cancer of Brain and Nervous System
  • Carcinoid Tumor
  • Carcinoma
  • Carcinoma of the Large Intestine
  • Carcinoma, Renal Cell
  • Carcinoma, Transitional Cell
  • Carcinomas
  • Cardiomyopathies
  • Cholangiocarcinoma
  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Colorectal Neoplasms
  • Endocrine Cancer
  • Esophageal Cancer
  • Esophageal Neoplasms
  • Eye Cancer
  • Gall Bladder Cancer
  • Gastric (Stomach) Cancer
  • Gastrointestinal Stromal Tumor (GIST)
  • Gastrointestinal Stromal Tumors
  • Gastrooesophageal Cancer
  • Gynecologic Cancers
  • Head and Neck Cancers
  • Head and Neck Neoplasms
  • Hepatobiliary Neoplasm
  • Hodgkin Disease
  • Kidney (Renal Cell) Cancer
  • Leukemia
  • Lung Cancer
  • Lymphoma, Non-Hodgkin
  • Mesothelioma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes (MDS)
  • Myeloproliferative Disorders
  • Neuroendocrine Tumors
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Preleukemia
  • Prostate Cancer
  • Sarcoma
  • Skin Cancer
  • Soft Tissue Sarcoma
  • Testicular Cancer
  • Testicular Neoplasms
  • Thymus Cancer
  • Thyroid Cancer
  • Thyroid Neoplasms
  • Transitional Cell Carcinoma of Bladder
  • Urinary Bladder Neoplasms

NCT number NCT01135849
Study type Observational
Source Stanford University
Contact
Status Completed
Phase N/A
Start date November 2008
Completion date October 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A