Childhood CancerNCT04036045
Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity
An observational study of Childhood Cancer, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
Early microRNAs (miRs) and Cardiac Magnetic Resonance (CMR)-derived strain analysis and detection of genes contributing to Anthracycline-Induced Cardiotoxicity (AIC) sensitivity and resistance will identify pediatric cancer patients most and least likely to develop AIC. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Cardiac MRI, Echocardiogram and Blood Draw
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Basis and Translational Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity
Early microRNAs (miRs) and Cardiac Magnetic Resonance (CMR)-derived strain analysis and detection of genes contributing to Anthracycline-Induced Cardiotoxicity (AIC) sensitivity and resistance will identify pediatric cancer patients most and least likely to develop AIC.
Read the detailed 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
- Conditions
- Childhood Cancer
- Being tested
- Cardiac MRI, Echocardiogram, Blood Draw
- Keywords
- Anthracycline induced cardiotoxicity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIOther
Also called cMRI
Patients will have a cardiac MRI at four time points during the study
EchocardiogramOther
Also called Echo
Patients will have an echocardiogram at four time points during the study
Blood DrawOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
CMR
- Increased myocardial T2 relaxation time in the myocardium compared to baseline as measured by T2 mapping technique
Measured: From Baseline to one year after anthracycline therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start12 Nov 2018 (estimated)
- Primary completionDec 2024 (estimated)
- Study completion31 Mar 2025
Why it stopped: No funding, no participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Olga Salazar, MD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036045
- Sponsor's protocol ID
- 18-137
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2019
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Basis and Translational Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity
- ClinicalTrials.gov ID
- NCT04036045
- Acronym / sponsor ID
- 18-137
- Conditions
- Childhood Cancer
- Keywords
- Anthracycline induced cardiotoxicity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding, no participation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 12 Nov 2018 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early microRNAs (miRs) and Cardiac Magnetic Resonance (CMR)-derived strain analysis and detection of genes contributing to Anthracycline-Induced Cardiotoxicity (AIC) sensitivity and resistance will identify pediatric cancer patients most and least likely to develop AIC.
Detailed 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIAlso: cMRIPatients will have a cardiac MRI at four time points during the study | Other | – |
| EchocardiogramAlso: EchoPatients will have an echocardiogram at four time points during the study | Other | – |
| Blood DrawPatients 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. | Other | – |
Primary outcome
CMR
Time frame: From Baseline to one year after anthracycline therapy
1. Increased myocardial T2 relaxation time in the myocardium compared to baseline as measured by T2 mapping technique
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Undecided. Pending
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Salazar, MD principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMR (time frame: From Baseline to one year after anthracycline therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.