NCT00636844

Brief Summary

To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

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

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 13, 2013

Status Verified

August 1, 2012

Enrollment Period

3.9 years

First QC Date

March 10, 2008

Last Update Submit

March 11, 2013

Conditions

Cancer

Keywords

chemotherapy, cardiotoxicity

Outcome Measures

Primary Outcomes (1)

  • The genetic profile of patients with anthracycline-induced elevation of troponin-I

    one year

Secondary Outcomes (2)

  • Assess the genetic profile of patient with anthracycline-induced left ventricular systolic and diastolic dysfunction

    one year

  • Assess the relationship of quantitative increases of pro-oxidant stress and a specific genetic profile

    one year

Study Arms (1)

Group A

Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Oncology clinic patients

You may qualify if:

  • undergoing anthracycline and/or trastuzumab therapy for the first time

You may not qualify if:

  • abnormal ventricular ejection fraction
  • past history of, or active cardiac disease including: MI, CHF, angina, arrhythmia requiring medication, valvular disease, uncontrolled systemic hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for analysis of mRNA and oxidative stress markers

MeSH Terms

Conditions

NeoplasmsCardiotoxicity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Officials

  • Jannet Lewis, MD

    George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 17, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

March 13, 2013

Record last verified: 2012-08

Locations

US(1)