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Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)

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Disease Information

Descriptive Information
Brief Title † Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)
Official Title † Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)
Brief Summary AML is a disease of older adults, with a median age at diagnosis of 67 years . An estimated 13,410 new cases of AML will be diagnosed in 2007. Survival for AML is age-dependent, with significantly lower survival rates reported for older adults. SEER statistics from 1996-2003 show a 5 year relative survival rate of 34.4% for adults younger than 65 and 4.3% for those ≥65 years of age 1. Clinical trials have demonstrated worse survival outcomes in older adults with AML using age cutoffs of 55, 60 and 65 years. Older adults have also experienced increased toxicity to standard therapies in clinical trials. Chronologic age cutoffs have therefore been used in research and clinical practice due to concerns regarding toxicity associated with treatment. The reasons for the increased toxicity and decreased survival in older adults with AML is incompletely understood and likely multifactorial including both tumor specific and host specific factors. Improving understanding of which measurable clinical characteristics predict vulnerability to toxicity will help refine the research and clinical approach to older adults with AML.
Detailed Description
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Overall Survival
Secondary Outcome Measure † Treatment Related Mortality
Condition † ACUTE MYELOGENOUS LEUKEMIA
Intervention † OtherBedside assessment
Study Arms / Comparison Groups Bedside Assessment Measures The study intervention consists of a bedside functional assessment to be administered to eligible, consented subjects who are hospitalized with a new diagnosis of AML or are undergoing workup for suspected AML diagnosis. All subjects will be enrolled within 5 days of admission to the hospital for known or suspected AML or within 5 days of new confirmed diagnosis of AML obtained during a hospitalization for other indications. All measures will be performed by a trained examiner during a face to face interview. Bedside assessment measures will be repeated once for subjects who complete induction chemotherapy within 2-8 weeks post discharge from initial hospitalization.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 82
Start Date † January 2009
Completion Date April 2011
Primary Completion Date April 2011
Eligibility Criteria † Inclusion Criteria: - Capacity to provide signed protocol specific informed consent - Age ≥ 60 years - Pathologically confirmed newly diagnosed AML or undergoing workup for suspected AML - Planned induction chemotherapy - Inpatient status Exclusion Criteria: - Requiring intensive care unit support during initial evaluation - Prior therapy for AML - ECOG score >3
Gender All
Ages 60 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT02662933
Organization ID CCCWFU 22A08
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Wake Forest University Health Sciences
Collaborators ††
Investigators † Principal Investigator: Heidi Klepin, MD, Wake Forest University Health Sciences
Information Provided By
Verification Date January 2016
First Received Date † January 19, 2016
Last Updated Date May 25, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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