Association Between Mitochondrial DNA Content and Risk of Acute Leukemia

July 8, 2020 updated by: Lipeng Liu, Air Force Military Medical University, China

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

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.

Study Overview

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
      • 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

No older than 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
acute leukemia group
150 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy
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).
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative copy number of mitochondrial DNA
Time Frame: From date of admission until the date of discharging from hospital, assessed up to 5 days
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

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)

November 1, 2018

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YL2018070101

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

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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