NCT01135849

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

June 1, 2010

Last Update Submit

November 16, 2015

Conditions

CarcinomasAmyloidosisAnal CancerAnemiaCholangiocarcinoma of the Extrahepatic Bile DuctTransitional Cell Carcinoma of BladderBone Marrow Transplant FailureBone CancerCancer of Brain and Nervous SystemBreast CancerCarcinoma of the Large IntestineEndocrine CancerEsophageal CancerEye CancerGall Bladder CancerGastric (Stomach) CancerGastrooesophageal CancerGastrointestinal Stromal Tumor (GIST)Gynecologic CancersHead and Neck CancersHepatobiliary NeoplasmKidney (Renal Cell) CancerLeukemiaLung CancerHodgkin DiseaseLymphoma, Non-HodgkinMesotheliomaMultiple MyelomaMyelodysplastic Syndromes (MDS)Neuroendocrine TumorsMyeloproliferative DisordersPancreatic CancerProstate CancerSkin CancerSoft Tissue SarcomaTesticular CancerThymus CancerThyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • Development of cardiomyopathy

    Decrease in fractional shortening below normal (\<28%)

    Within 5 years after receiving anthracyclines.

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients exposed to anthracycline who have had an echocardiogram at least six months after initial exposure.

You may qualify if:

  • ) 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)
  • ) 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..

You may not qualify if:

  • ) Pre-existing cardiomyopathy before anthracycline administration
  • ) Patients with Down syndrome
  • ) Patients receiving B-blocker therapy at the time of anthracycline exposure
  • ) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cheek swab or blood drawn for DNA extraction

MeSH Terms

Conditions

CarcinomaAmyloidosisAnus NeoplasmsAnemiaBone NeoplasmsBrain NeoplasmsNeurologic ManifestationsBreast NeoplasmsColonic NeoplasmsEndocrine Gland NeoplasmsEsophageal NeoplasmsEye NeoplasmsGallbladder NeoplasmsStomach NeoplasmsGastrointestinal Stromal TumorsHead and Neck NeoplasmsCarcinoma, Renal CellLeukemiaLung NeoplasmsHodgkin DiseaseLymphoma, Non-HodgkinMesotheliomaMultiple MyelomaMyelodysplastic SyndromesNeuroendocrine TumorsMyeloproliferative DisordersPancreatic NeoplasmsProstatic NeoplasmsSkin NeoplasmsSarcomaTesticular NeoplasmsThymus NeoplasmsThyroid Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBone DiseasesMusculoskeletal DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColonic DiseasesEndocrine System DiseasesEsophageal DiseasesEye DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueAdenocarcinomaKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAdenomaNeoplasms, MesothelialNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissuePancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesTesticular DiseasesGonadal DisordersThyroid Diseases

Study Officials

  • Daniel Bernstein

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 3, 2010

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(1)