- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409379
Association Between Telomere Length and Cardiac Dysfunction
May 27, 2020 updated by: Lipeng Liu, Air Force Military Medical University, China
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
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Tianjin, Tianjin, China, 300000
- Xiao-Fan Zhu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A total of 300 eligible acute leukemia patients were anticipated to include in this study.
Description
Inclusion Criteria:
- 1. histological confirmed acute leukemia; 2. Preparing for chemotherapy;
Exclusion Criteria:
- 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
acute leukemia group
300 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy
|
Relative telomere length in peripheral blood cell
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From date of admission until the date of discharging from hospital, assessed up to 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
May 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
May 27, 2020
First Submitted That Met QC Criteria
May 27, 2020
First Posted (Actual)
June 1, 2020
Study Record Updates
Last Update Posted (Actual)
June 1, 2020
Last Update Submitted That Met QC Criteria
May 27, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YL2019100602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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