NCT01869777

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

May 31, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 27, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 13, 2020

Status Verified

May 1, 2020

Enrollment Period

4.7 years

First QC Date

May 31, 2013

Results QC Date

February 28, 2020

Last Update Submit

July 30, 2020

Conditions

Acute Undifferentiated LeukemiaAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Mast Cell LeukemiaMyeloid/NK-cell Acute LeukemiaUntreated Adult Acute Lymphoblastic LeukemiaUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

    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

    60 days

Secondary Outcomes (7)

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

    30 days

  • Length of Hospitalization

    Up to 2 years

  • Number of Participants Transferred to Intensive Care Unit During Induction

    Up to 2 years

  • Number of Participants With Bone Marrow Response

    14 days

  • Number of Participants to Achieve Complete Remission

    Up to 2 years

  • +2 more secondary outcomes

Study Arms (1)

Diagnostic (bioelectric impedance analysis)

EXPERIMENTAL

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.).

Procedure: bioelectric impedance analysis

Interventions

bioelectric impedance analysisPROCEDURE

Undergo bioelectric impedance analysis

Also known as: BIA, bioelectric impedance, bioelectric impedance test, bioimpedance analysis
Diagnostic (bioelectric impedance analysis)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized for newly diagnosed acute leukemia
  • Receiving induction treatment while hospitalized
  • Willing and able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Leukemia, Biphenotypic, AcuteCongenital AbnormalitiesLeukemia, Mast-Cell

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myeloid, AcuteLeukemia, MyeloidMastocytosis, SystemicMastocytosisMast Cell Activation Disorders

Results Point of Contact

Title
Principal investigator
Organization
Wake Forest University Health Sciences
tpardee@wakehealth.edu
336-716-5440

Study Officials

  • Timothy Pardee

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2013

First Posted

June 5, 2013

Study Start

July 1, 2013

Primary Completion

March 19, 2018

Study Completion

May 1, 2020

Last Updated

August 13, 2020

Results First Posted

April 27, 2020

Record last verified: 2020-05

Locations

US(1)