TriangleNCT01869777 · STUDY IN CONTEXT
Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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
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.
A linear model will be used to look at the association of standardized phase angle and length of hospital stay.
Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.
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).
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
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- trial label
- Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0000
- source section id
- NCT01869777-om-0000
- source outcome index
- 0
- endpoint
- Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration
- endpoint definition
- 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
- time origin
- 60 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0001
- source section id
- NCT01869777-om-0001
- source outcome index
- 1
- endpoint
- Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration
- endpoint definition
- 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.
- time origin
- 30 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0002
- source section id
- NCT01869777-om-0002
- source outcome index
- 2
- endpoint
- Length of Hospitalization
- endpoint definition
- A linear model will be used to look at the association of standardized phase angle and length of hospital stay.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0003
- source section id
- NCT01869777-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants Transferred to Intensive Care Unit During Induction
- endpoint definition
- Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0004
- source section id
- NCT01869777-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Bone Marrow Response
- endpoint definition
- 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).
- time origin
- 14 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 14 participants excluded in analysis due to 14-day bone marrow data not available.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0005
- source section id
- NCT01869777-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants to Achieve Complete Remission
- endpoint definition
- 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
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Diagnostic (Bioelectric Impedance Analysis)
- regimen
- 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
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01869777-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Diagnostic (Bioelectric Impedance Analysis)
- regimen
- 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
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01869777-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Diagnostic (Bioelectric Impedance Analysis)
- regimen
- 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
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01869777-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Diagnostic (Bioelectric Impedance Analysis)
- regimen
- 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
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01869777-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Diagnostic (Bioelectric Impedance Analysis)
- regimen
- 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
- analyzed count
- 87
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01869777-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Diagnostic (Bioelectric Impedance Analysis)
- regimen
- 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
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01869777-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT01869777
- harm key
- EG000
- source section id
- NCT01869777-ae
- event group key
- EG000
- event group label
- Diagnostic (Bioelectric Impedance Analysis)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Up to 2 years to assess for survival only
- event definition
- Adverse events were not monitored/assessed for this trial.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice