Cardiac ToxicityNCT04409379
Association Between Telomere Length and Cardiac Dysfunction
An observational study of Cardiac Toxicity and Acute Leukemia, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Compelling epidemiological evidence indicates that alterations of relative telomere length (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute leukemia (AL).The aim of this study was to explore association between RTL content in peripheral blood cells could be used as a risk… Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Toxicity, Acute Leukemia, Childhood Cancer
- What is being tested?
- Relative telomere length
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 May 2020
- 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 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 300 eligible acute leukemia patients were anticipated to include in this study.
Who may be able to join
- 1. histological confirmed acute leukemia; 2. Preparing for chemotherapy;
Who cannot join
- 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Relative Telomere Length and Severity of Cardiac Dysfunction
Compelling epidemiological evidence indicates that alterations of relative telomere length (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute leukemia (AL).The aim of this study was to explore association between RTL content in peripheral blood cells could be used as a risk predictor for severity of cardiac damage.
- Conditions
- Cardiac Toxicity, Acute Leukemia, Childhood Cancer
- Being tested
- Relative telomere length
- Medical subject headings
- Cardiotoxicity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relative telomere lengthDiagnostic test
Relative telomere length in peripheral blood cell
| Study group | Role | What they receive |
|---|---|---|
| acute leukemia group | 300 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy Receives: Diagnostic Test: Relative telomere length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative telomere length
The ratio of RTL to hemoglobin contents was calculated for each sample from standard curves. After that, the ratio for each sample was normalized to a calibrator DNA in order to standardize between different runs, and then defined as the measurement of relative mtDNA contents.Relative expression of mtDNA were measured in young adults suffered from AL.
Measured: From date of admission until the date of discharging from hospital, assessed up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jan 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ToxicityStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lipeng Liu, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409379
- Sponsor's protocol ID
- YL2019100602
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Relative Telomere Length and Severity of Cardiac Dysfunction
- ClinicalTrials.gov ID
- NCT04409379
- Acronym / sponsor ID
- YL2019100602
- Conditions
- Cardiac Toxicity, Acute Leukemia, Childhood Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 1 Jun 2020 (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.
Compelling epidemiological evidence indicates that alterations of relative telomere length (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute leukemia (AL).The aim of this study was to explore association between RTL content in peripheral blood cells could be used as a risk predictor for severity of cardiac damage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute leukemia group | – | Diagnostic Test: Relative telomere length300 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 300 eligible acute leukemia patients were anticipated to include in this study.
Key inclusion criteria (1 listed)
- 1. histological confirmed acute leukemia; 2. Preparing for chemotherapy;
Key exclusion criteria (1 listed)
- 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.
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 |
|---|---|---|
| Relative telomere lengthRelative telomere length in peripheral blood cell | Diagnostic test | acute leukemia group |
Primary outcome
Relative telomere length
Time frame: From date of admission until the date of discharging from hospital, assessed up to 5 days
The ratio of RTL to hemoglobin contents was calculated for each sample from standard curves. After that, the ratio for each sample was normalized to a calibrator DNA in order to standardize between different runs, and then defined as the measurement of relative mtDNA contents.Relative expression of mtDNA were measured in young adults suffered from AL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Toxicity and Acute Leukemia, run by Air Force Military Medical University, China at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Jun 2020. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative telomere length (time frame: From date of admission until the date of discharging from hospital, assessed up to 5 days). 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 1 Jun 2020.