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Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity

Studies

Study First Submitted Date 2019-07-25
Study First Posted Date 2019-07-29
Last Update Posted Date 2023-02-06
Start Month Year January 2024
Primary Completion Month Year August 2028
Verification Month Year February 2023
Verification Date 2023-02-28
Last Update Posted Date 2023-02-06

Detailed Descriptions

Sequence: 20750955
Description Plan is to enroll 110 children and adults (≥9 years old) newly diagnosed at CCMC and Nationwide Children’s Hospital (55 per institution) who will receive anthracyclines as part of their chemotherapy regimen.

The duration of study participation will be approximately a year.

Patients will have a total of four study visits:

Baseline

1 week after patient’s anthracycline cumulative dose hits between 60 and 100 mg/m2 After the patient has completed maximal therapy One year after completion of anthracycline treatments

Study tasks for all four visits will be:

Collection of clinical data Blood draw for micro RNA and Biomarkers Cardiac MRI Echocardiogram One time blood draw for genetics

Facilities

Sequence: 200355609
Name Olga Salazar
City Hartford
State Connecticut
Zip 06106
Country United States

Facility Contacts

Sequence: 28141672
Facility Id 200355609
Contact Type primary
Name Olga Salazar, MD
Email otoro@connecticutchildrens.org
Phone 860-545-9410

Conditions

Sequence: 52245777
Name Childhood Cancer
Downcase Name childhood cancer

Id Information

Sequence: 40213181
Id Source org_study_id
Id Value 18-137

Countries

Sequence: 42628130
Name United States
Removed False

Interventions

Sequence: 52559239 Sequence: 52559240 Sequence: 52559241
Intervention Type Other Intervention Type Other Intervention Type Other
Name Cardiac MRI Name Echocardiogram Name Blood Draw
Description Patients will have a cardiac MRI at four time points during the study Description Patients will have an echocardiogram at four time points during the study Description Patients will have blood drawn at four time points to analyze micro RNAs and Biomarkers before, during and after anthracycline treatment. Patients will also have one blood draw for future genetic sequencing.

Keywords

Sequence: 79974632
Name Anthracycline induced cardiotoxicity
Downcase Name anthracycline induced cardiotoxicity

Design Outcomes

Sequence: 177652997
Outcome Type primary
Measure CMR
Time Frame From Baseline to one year after anthracycline therapy
Description 1. Increased myocardial T2 relaxation time in the myocardium compared to baseline as measured by T2 mapping technique

Browse Conditions

Sequence: 193771601 Sequence: 193771602 Sequence: 193771603 Sequence: 193771604 Sequence: 193771605 Sequence: 193771606 Sequence: 193771607 Sequence: 193771608
Mesh Term Cardiotoxicity Mesh Term Heart Diseases Mesh Term Cardiovascular Diseases Mesh Term Pathologic Processes Mesh Term Drug-Related Side Effects and Adverse Reactions Mesh Term Chemically-Induced Disorders Mesh Term Radiation Injuries Mesh Term Wounds and Injuries
Downcase Mesh Term cardiotoxicity Downcase Mesh Term heart diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term pathologic processes Downcase Mesh Term drug-related side effects and adverse reactions Downcase Mesh Term chemically-induced disorders Downcase Mesh Term radiation injuries Downcase Mesh Term wounds and injuries
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48389430 Sequence: 48389431
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Connecticut Children’s Medical Center Name Nationwide Children’s Hospital

Overall Officials

Sequence: 29326028
Role Principal Investigator
Name Olga Salazar, MD
Affiliation Connecticut Children’s Medical Center

Central Contacts

Sequence: 12026008
Contact Type primary
Name Olga Salazar, MD
Phone 860-545-9400
Email Otoro@connecticutchildrens.org
Role Contact

Eligibilities

Sequence: 30809028
Sampling Method Non-Probability Sample
Gender All
Minimum Age 9 Years
Maximum Age 18 Years
Healthy Volunteers No
Population Patients who are > or equal to 9 years of age who are newly diagnosed with cancer who will receive anthracycline (s) as part of the their treatment regimen.
Criteria Inclusion Criteria:

Age (≥ 9years old)
Newly diagnosed with a malignancy that will receive ACs as part of their chemotherapy.
Parental/caregiver consent and subject assent to enrollment.

Exclusion Criteria:

Subject has contraindications to CMR.*
Subject requiring sedation for CMR
Subject too large to be safely accommodated by CMR
Pregnancy tests are done routinely prior to chemotherapy, if test is positive the patient will be excluded
Subject’s serum creatinine above guidelines for adequate renal function. See table below:

Age (years) Male Female 6-10 1.0 mg/dL 1.0 mg/dL 10-13 1.2 mg/dL 1.2 mg/dL 13-16 1.5 mg/dL 1.4 mg/dL >16 1.7 mg/dL 1.4 mg/dL

Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254034621
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 9
Maximum Age Num 18
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30555017
Observational Model Case-Only
Time Perspective Prospective

Intervention Other Names

Sequence: 26706941 Sequence: 26706942
Intervention Id 52559239 Intervention Id 52559240
Name cMRI Name Echo

Responsible Parties

Sequence: 28921390
Responsible Party Type Principal Investigator
Name Olga Salazar
Title Principal Investigator
Affiliation Connecticut Children’s Medical Center