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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00964 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU 99113 | Other Identifier | Wake Forest University Health Sciences |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bioelectric impedance analysis | Procedure | Undergo bioelectric impedance analysis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration | 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Pardee | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Bioelectric Impedance Analysis) | 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2014 |
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| Length of Hospitalization |
A linear model will be used to look at the association of standardized phase angle and length of hospital stay. |
| Up to 2 years |
| Number of Participants Transferred to Intensive Care Unit During Induction | Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit. | Up to 2 years |
| Number of Participants With Bone Marrow Response | 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). | 14 days |
| Number of Participants to Achieve Complete Remission | 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 | Up to 2 years |
| Number of Participants With Receipt of Post-Remission Therapy | Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy. | Up to 2 years |
| Overall Survival | Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model. | Up to 2 years |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Bioelectric Impedance Analysis) | 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 60 days |
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| Secondary | Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration | 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. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Length of Hospitalization | A linear model will be used to look at the association of standardized phase angle and length of hospital stay. | Posted | Mean | Standard Deviation | Days | Up to 2 years |
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| Secondary | Number of Participants Transferred to Intensive Care Unit During Induction | Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit. | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Number of Participants With Bone Marrow Response | 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). | 14 participants excluded in analysis due to 14-day bone marrow data not available. | Posted | Count of Participants | Participants | 14 days |
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| Secondary | Number of Participants to Achieve Complete Remission | 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 | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Number of Participants With Receipt of Post-Remission Therapy | Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy. | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Overall Survival | Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model. | Posted | Median | 95% Confidence Interval | Days | Up to 2 years |
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Up to 2 years to assess for survival only
Adverse events were not monitored/assessed for this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Bioelectric Impedance Analysis) | 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis | 16 | 101 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal investigator | Wake Forest University Health Sciences | 336-716-5440 | tpardee@wakehealth.edu |
| Feb 28, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 21, 2018 | Jul 30, 2020 | ICF_002.pdf |
| ID | Term |
|---|---|
| D015456 | Leukemia, Biphenotypic, Acute |
| D000013 | Congenital Abnormalities |
| D007946 | Leukemia, Mast-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D034721 | Mastocytosis, Systemic |
| D008415 | Mastocytosis |
| D000090362 | Mast Cell Activation Disorders |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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