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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04409379
Other study ID # YL2019100602
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date May 1, 2020

Study information

Verified date May 2020
Source Fourth Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 predictor for severity of cardiac damage.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 16 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Relative telomere length
Relative telomere length in peripheral blood cell

Locations

Country Name City State
China Xiao-Fan Zhu Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From date of admission until the date of discharging from hospital, assessed up to 5 days
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