NCT02798679

Brief Summary

The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

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

First Submitted

Initial submission to the registry

May 12, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

6.1 years

First QC Date

May 12, 2016

Last Update Submit

October 15, 2022

Conditions

Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

  • Cardiotoxicity assessed clinically or by cardiac MRI

    24 months

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive participants with breast cancer or lymphoma scheduled to receive anthracycline-based chemotherapy or trastuzumab.

You may qualify if:

  • Stage I-III breast cancer or lymphoma with a \>2 year life expectancy
  • A treatment plan that includes anthracyclines and/or trastuzumab
  • Age \>45 years
  • Able to hold breath for 10 seconds
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

You may not qualify if:

  • Refusal or inability to provide informed consent
  • Known heart failure or LVEF \<50%
  • Heart rate over 100 bpm
  • Renal dysfunction with GFR \<30 mL/min/1.73m2
  • Participants with pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
  • Symptomatic claustrophobia
  • Plans to move within 24 months of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Chetan Shenoy, MBBS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 12, 2016

First Posted

June 14, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)