NCT04409379

Brief Summary

Compelling epidemiological evidence indicates that alterations of relative telomere length (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute leukemia (AL).The aim of this study was to explore association between RTL content in peripheral blood cells could be used as a risk predictor for severity of cardiac damage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

May 27, 2020

Last Update Submit

May 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relative telomere length

    The ratio of RTL 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 AL.

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

Study Arms (1)

acute leukemia group

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

Diagnostic Test: Relative telomere length

Interventions

Relative telomere length in peripheral blood cell

acute leukemia group

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A total of 300 eligible acute leukemia patients were anticipated to include in this study.

You may qualify if:

  • \. histological confirmed acute leukemia; 2. Preparing for chemotherapy;

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiao-Fan Zhu

Tianjin, Tianjin Municipality, 300000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Relative telomere length in peripheral blood cell

MeSH Terms

Conditions

CardiotoxicityNeoplasms

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 1, 2020

Study Start

January 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations