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Long NameStaging, Leukemia NCI Standard Template
DefinitionThe collection of CDEs used in the leukemia staging module
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3461076
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Leukemia Staging QuestionsThese items must be included when this data is collected for reporting.
Date Current Staging Assessment CompletedCurrent Stage Complete Assessment Date627393.0DATEMM/DD/YYYY
Conditional Leukemia Staging QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Binet StageBinet Staging System Stage28486501.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
ABinet Stage APatients have no anemia or thrombocytopenia and fewer than three areas of lymphoid involvement.
BBinet Stage BPatients have no anemia or thrombocytopenia and three or more areas of lymphoid involvement.
CBinet Stage CPatients have anemia and/or thrombocytopenia regardless of the number of areas of lymphoid involvement.
Rai Stage ClassificationCLL Leukemia RAI Stage582083.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
Stage 0 Lymphocytosis in blood with lymphocyte count > 15,000/mcl and bone marrow populated with mature lymphocytes comprising >40% of nucleated cellsLymphocytosis in blood with lymphocyte count > 15,000/mcl and bone marrow populated with mature lymphocytes comprising >40% of nucleated cells
Stage ISAME AS STAGE 0 WITH LYMPHADENOPATHYSAME AS STAGE 0 WITH LYMPHADENOPATHY
Stage IIINCLUDES SAME DEGREE OF LYMPHOCYTOSIS AS STAGE 0, PLUS ENLARGED SPLEEN AND/OR LIVERINCLUDES SAME DEGREE OF LYMPHOCYTOSIS AS STAGE 0, PLUS ENLARGED SPLEEN AND/OR LIVER
Stage III Includes lymphocytosis and anemia defined as Hgb <11 g/dl or Hct <33%. Physical findings of lymphadenopathy, hepatomegaly or splenomegaly are not required. No distinction with regard to type of anemia (i.e. hemolytic) is madeIncludes lymphocytosis and anemia defined as Hgb <11 g/dl or Hct <33%. Physical findings of lymphadenopathy, hepatomegaly or splenomegaly are not required. No distinction with regard to type of anemia (i.e. hemolytic) is made
Stage IVIncludes the findings at diagnosis of lymphocytosis as defined in Stage 0, with thrombocytopenia <100,000/mcl. Anemia and organomegaly may be absent.Includes the findings at diagnosis of lymphocytosis as defined in Stage 0, with thrombocytopenia <100,000/mcl. Anemia and organomegaly may be absent.
CML PhaseCML Disease Phase Category29023961.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
Accelerated phaseAccelerated Phase Chronic Myelogenous LeukemiaNo Value Exists
Blastic phaseBlast Phase Chronic Myelogenous LeukemiaAn advanced phase of chronic myelogenous leukemia. It is characterized a. by the presence of blasts in the peripheral blood or bone marrow that are at least 20% of the peripheral blood white cells or of the nucleated cells in the bone marrow respectively, or b. an extramedullary proliferation of blasts, and/or c. when there are large aggregates and clusters of blasts in the bone marrow biopsy specimen (adapted from WHO, 2001).
Chronic phaseChronic Phase Chronic Myelogenous LeukemiaA phase of chronic myelogenous leukemia in which the peripheral blood smear shows leukocytosis due mainly to neutrophils in different stages of maturation. Blasts usually account for less than 2% of the white blood cells counts. The platelet count is normal or increased. Thrombocytopenia is very uncommon during the chronic phase. Most patients have mild anemia. The bone marrow biopsy is hypercellular due to increased numbers of neutrophils and their precursors. Blasts usually account for fewer than 5% of the marrow cells, and more than 10% indicates transformation to the accelerated phase. Megakaryocytes are smaller than normal and have hypolobated nuclei. The spleen is enlarged due to infiltration of the cords of the red pulp by granulocytes. Most patients with chronic myelogenous leukemia are diagnosed in the chronic phase, which usually has an insidious onset and may last from several months to several years. (WHO, 2001)
Optional Leukemia Staging QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
Staging Time PointDisease Staging Timepoint Name28473521.0CHARACTER
Current DiagnosisCurrent DiagnosisOccurring in or belonging to the present time.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
Initial DiagnosisFirst DiagnosisPreceding all others in time or space or degree.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
RestagingRestagingRepeat of staging assessment
Study EnrollmentClinical Study EnrollmentResearch conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, mechanism of human diseases, therapy, clinical trials, epidemiology, behavior and health services research. : Enrollment; to insert, register, or enter in a list, catalog, or roll. (Merriam-Webster Online)