Transient Elastgraphy fo pediatric patients with acute lymphoblastic leukemia to evaluate liver steatosis

JRCT ID: jRCT1032210047

Registered date:22/04/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: de novo acute lymphoblastic leukemia
• Date of first enrollment: 27/09/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): After enrollment, we will evaluate CAP value using transient elastography to assess steatosis before initiating the treatment for acute lymphoblastic leukemia. CAP value is measured with evaluating cirrhosis. Cirrhosis is evaluated when successful measurement was obtained 10 or more times, successful rate is 60% or more, and IQR/median (%) of the measurement is 30% or more. The median CAP value in that circumstance is determined as a CAP value. The transient elastography will be performed after induction therapy, early intensification therapy, and the last intensification study.

Outcome(s)

• Primary Outcome: The proportion of patients whose Controlled Attenuation Parameter (CAP) were above 225 dB/m.

Secondary Outcome

To compare of CAP between pretreatment and post-induction therapy.
To investigate chronological changes of CAP.
To evaluate factors of CAP > 225 dB/, after induction therapy (AST, ALT, total cholesterol, triglyceride)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 20age old
• Gender: Both

Include criteria

1. De novo pediatric patients (age < 20 years old) who were diagnosed as acute lymphoblastic leukemia, planning to perform chemotherapy in our hospital.
2. Performance status 0-2
3. Patients whose legal gurdians provide written informed consents.

Exclude criteria

1. Patients who have chronic hepatitis such as HBV or HCV.
2. Patients who are extremely anxious for the exam.
3. Patients who are allergic to ultrasound gel.
4. Patients whose body mass index are more than 30.
5. Patients who have preivious hisotory of malignant diseases or cancer chemotherapy.
6. Other reasons for inapproate candidates of this study.

Related Information

• Primary Sponsor: Tanoshima Reo