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CompletedNCT03595969Updated Jul 10, 2020

Association Between Mitochondrial DNA Content and Risk of Acute Leukemia

An observational study in Lymphoblastic Leukemia in Children, sponsored by Air Force Military Medical University, China. Completed at 1 site in China. Open to participants aged Up to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-10.

Sponsored by Air Force Military Medical University, China · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Ages
Up to 16 Years
Sex
All
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Study 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.

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Conditions studied

  • Lymphoblastic Leukemia in Children

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Keywords

  • mitochondrial DNA
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In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's enrollment of 300 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A total of 150 eligible chronic lymphocytic leukemia patients were anticipated to include in this study. Moreover, 50 healthy controls without previous cancer history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • acute leukemia group

    150 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy

    Diagnostic Test: Relative copy number of mitochondrial DNA

  • Control group

    The 50 healthy controls without previous cancer history were recruited from individuals who visited investigator's hospital for physical examination during the same time period as the case enrollment.

    Diagnostic Test: Relative copy number of mitochondrial DNA

Interventions

  • Diagnostic testRelative 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).

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From date of admission until the date of discharging from hospital, assessed up to 5 days

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Study locations

1 site
  • Xiao-Fan Zhu
    Tianjin, Tianjin 300000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03595969
Lead sponsor
Air Force Military Medical University, China
Collaborators
Chinese Academy of Medical Sciences
Responsible party
Lipeng Liu (M.D., Chinese Academy of Medical Sciences) — Principal investigator
First posted
Jul 23, 2018
Start date
Nov 1, 2018
Primary completion
Oct 1, 2019
Completion
Oct 1, 2019
Last update
Jul 10, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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