NCT01869777 · REGISTRY CONDITION SEARCH

Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2020-08-13

This clinical trial studies bioelectrical impedance measurement for predicting treatment outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as bioelectrical impedance measurement, may help predict a patient's response to treatment for acute leukemia.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration

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outcome · POSTED

Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration

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outcome · POSTED

Length of Hospitalization

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outcome · POSTED

Number of Participants Transferred to Intensive Care Unit During Induction

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outcome · POSTED

Number of Participants With Bone Marrow Response

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outcome · POSTED

Number of Participants to Achieve Complete Remission

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outcome · POSTED

Number of Participants With Receipt of Post-Remission Therapy

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Hospitalized for newly diagnosed acute leukemia * Receiving induction treatment while hospitalized * Willing and able to provide written informed consent Exclusion Criteria: * Presence of a pacemaker or defibrillator * Patients pregnant at the time of enrollment * Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients * Unable/unwilling to follow protocol requirements
healthy Volunteers: false
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement just prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, PICC line placement, etc.).
intervention Names
Procedure: bioelectric impedance analysis
label
Diagnostic (bioelectric impedance analysis)
type
EXPERIMENTAL

interventions

arm Group Labels
Diagnostic (bioelectric impedance analysis)
description
Undergo bioelectric impedance analysis
name
bioelectric impedance analysis
other Names
BIA
bioelectric impedance
bioelectric impedance test
bioimpedance analysis
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

DIAGNOSTIC

Enrollment

count: 102
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Logistic regression will be used to analyze the association between standardized phase angle and 60 day mortality. 60 day mortality rate is defined as the percent of patients no longer alive at 60 days after registration. Patients that are discharged to hospice care before 60 days without a known date of death will be counted towards 60 day mortality
measure
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration
time Frame
60 days

secondary Outcomes

description
Logistic regression will be used to analyze the association between standardized phase angle and 30 day mortality. 30 day mortality rate is defined as the percent of patients no longer alive at 30 days after registration.
measure
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration
time Frame
30 days
description
A linear model will be used to look at the association of standardized phase angle and length of hospital stay.
measure
Length of Hospitalization
time Frame
Up to 2 years
description
Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.
measure
Number of Participants Transferred to Intensive Care Unit During Induction
time Frame
Up to 2 years
description
Logistic regression will be used to analyze the significant association between standardized phase angle and marrow response at 14-day bone marrow biopsy to show the odds of having 14-day residual disease (presence cancer cells remaining after treatment) and non-residual disease (no cancer cells remaining after treatment). (14 day bone marrow response is defined as hypoplastic marrow with less than 20% cellularity and 5% blasts. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count \>1000, platelet count \>100,000 and freedom from red cell transfusions).
measure
Number of Participants With Bone Marrow Response
time Frame
14 days
description
Logistic regression will be used to analyze the association between standardized phase angle and complete remission. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count \> 1000, platelet count \> 100,000 and freedom from red cell transfusions
measure
Number of Participants to Achieve Complete Remission
time Frame
Up to 2 years
description
Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.
measure
Number of Participants With Receipt of Post-Remission Therapy
time Frame
Up to 2 years
description
Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.
measure
Overall Survival
time Frame
Up to 2 years

Full study description

brief Summary: This clinical trial studies bioelectrical impedance measurement for predicting treatment outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as bioelectrical impedance measurement, may help predict a patient's response to treatment for acute leukemia.
detailed Description: PRIMARY OBJECTIVES: I: To determine the feasibility of obtaining standardized phase angle measurements (bioelectrical impedance measurement) on patients hospitalized for treatment of newly diagnosed acute leukemia. II. To evaluate the association between standardized phase angle measured at the start of therapy and treatment-related outcomes including treatment related mortality (defined as 60-day mortality) III. Evaluate the association of the day 14 standardized phase angle and treatment related outcomes, 30-day mortality, length of hospitalization, transfer to intensive care unit during induction, treatment response (14 day bone marrow response, complete remission), receipt of post-remission therapy, overall survival. IV. An exploratory analysis investigating associations with the primary and secondary outcomes using different ways to categorize the baseline standardized phase angle and, for acute myeloid leukemia (AML) patients, the standardized phase angle measure obtained just prior to the nadir marrow. OUTLINE: Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, peripherally inserted central catheter \[PICC\] line placement, etc.). After completion of study treatment, patients are followed up for two years.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice