Early Detection of Heart Problems in Cancer Patients Rece... | NCT04413487

Studies
Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy

NCT04413487

Sponsor

The Guthrie Clinic

Status

Withdrawn

Last Update Posted

Jun 4, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Extra echocardiogram

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never started due to change in standard of care guideline

Expanded Access Info

Start Date

Mar 2020Estimated

Primary Completion Date

May 28, 2020Actual

Completion Date

May 28, 2020Actual

First Submitted Date

Dec 9, 2019

First Submission Date that Met QC Criteria

May 28, 2020

First Posted Date

Jun 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease. Subjects will received an extra echocardiogram to determine if heart problems can be detected earlier.

Detailed Description

Patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline echocardiogram as per standard protocol which should be covered by the routine insurance
Follow-up with an extra echocardiogram for research purposes would be performed after 2 cycles of that chemotherapy - supplied by the study
Clinical assessment at 3 to 6 months including repeat echocardiography as per standard care with the research question as whether any differences in strain pattern between pre-chemo and post 2 cycles studies all identify patients who are more likely to have cardiac issues later.
Patients will have standard of care visits at 3 month, 6 month and 12 month and will be evaluated for cardiac status and survival.
Patient records will be reviewed at 5 years to check cardiac status and survival.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Extra echocardiogram	Other	Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in left ventricular ejection fraction (LVEF)	a decrease in LVEF of ≥10 percentage points from baseline to a value of < 50% OR a decrease of LVEF by ≥ 5 percentage points from baseline to LVEF <50% for patients who have a baseline LVEF of 50-54%	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Survival status	alive or deceased	through study completion, an average of 1 year
Change in symptoms that may be indicative of heart failure	Presence of absence of symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females 18 years and above
Willing and able to provide consent
Able to read
Patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab.
Patients at increased risk of cardiotoxicity with one or more risk factors for heart disease:
- LVEF 50-54% by baseline echocardiogram
- Age ≥ 65
- BMI ≥ 30 kg/m2
- Current or prior anti-hypertensive therapy
- Diagnosis of coronary artery disease (CAD)
- Diabetes Mellitus
- Atrial fibrillation/flutter

Exclusion Criteria:

Children
Patients who are pregnant
Only single encounter without follow up
Cancer diagnosis other than breast or hematological cancer
Chemotherapy treatment other than anthracycline or trastuzumab
No prior chemotherapy treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease including LVEF 50-54% by baseline echocardiogram; Age ≥ 65; BMI ≥ 30 kg/m2;current or prior anti-hypertensive therapy; diagnosis of coronary artery disease (CAD); Diabetes Mellitus or Atrial fibrillation/flutter.

Sampling Method

Non-Probability Sample

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases