Association Between Mitochondrial DNA Content and Risk of Acute Leukemia

Lymphoblastic Leukemia in Children Clinical Trial

Official title:

Association Between Mitochondrial DNA Content and Risk of Acute Leukemia in Young Adult

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595969
• Other study ID #: YL2018070101
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2020
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of acute lymphoblastic leukemia (ALL).The aim of this study was to explore association between mtDNA content in peripheral blood cells could be used as a risk predictor for ALL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• 1.histological confirmed chronic lymphocytic leukemia; 2.preparing for chemotherapy; 3.no preoperative anticancer treatment.

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.

Related Conditions & MeSH terms

• Leukemia
• Lymphoblastic Leukemia in Children

Intervention

Diagnostic Test:
• Relative copy number of mitochondrial DNA
Mitochondria are responsible for multiple cellular functions including regulation of energy production, modulation of oxidation-reduction status, generation of reactive oxygen species and apoptosis. Each mitochondrion possesses multiple copies of a mitochondrial genome comprised of independently replicating double stranded DNA (mtDNA).

Locations

Country	Name	City	State
China	Xiao-Fan Zhu	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Fourth Military Medical University	Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative copy number of mitochondrial DNA	The ratio of mitochondrial DNA contents 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 chronic lymphocytic leukemiawhen compared with control group.	From date of admission until the date of discharging from hospital, assessed up to 5 days