Association Between Mitochondrial DNA Content and Risk of Acute Leukemia

Completed

• Conditions: Lymphoblastic Leukemia in Children
• Interventions: Diagnostic Test: Relative copy number of mitochondrial DNA

• Registration Number: NCT03595969
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-23
• Study Start: 2018-11-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute leukemia group	Relative copy number of mitochondrial DNA	150 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy
Control group	Relative copy number of mitochondrial DNA	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.

Primary Outcome Measures

Name	Time	Method
Relative copy number of mitochondrial DNA	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.

Trial Locations

Locations (1)

Xiao-Fan Zhu; 🇨🇳 Tianjin, Tianjin, China