Association Between Mitochondrial DNA Content and Risk of Acute Leukemia

NCT03595969 | Completed

• 1 other identifier: YL2018070101
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoblastic Leukemia in Children

Keywords

mitochondrial DNA

Outcome Measures

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.

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

Study Arms (2)

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

Relative copy number of mitochondrial DNA DIAGNOSTIC_TEST

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; acute leukemia group

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Xiao-Fan Zhu

Tianjin, Tianjin Municipality, 300000, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: November 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)