Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (DMD ...

Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (DMD) Common Data Elements (CDEs)

The Laboratory Tests CDE recommendations have been divided into separate categories and sorted alphabetically. The recommendations are presented in different tables as shown below:

? Table 1 ? CBC with Differential ? Table 2 ? Chemistries ? Table 3 ? CSF ? Table 4 ? CSF Culture ? Table 5 ? Blood Tests ? Table 6 ? Blood Gas Tests ? Table 7 ? Urinalysis ? Table 8 ? Scalp Electroencephalogram ? Table 9 ? Immune Cell Subsets

The tables provide an extensive list of the possible laboratory tests that may be collected in a study. While this list is broad, it is not exhaustive. The Laboratory Tests have all been recommended as supplemental or exploratory as the type of laboratory tests collected is dependent on the nature of the study and therefore none of the recommendations are considered core.

The list should be used in conjunction with the Laboratory Tests and Tracking Case Report Form (CRF).

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Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (DMD) Common Data Elements (CDEs)

Table 1. CBC with Differential

CDE Absolute Basophils Absolute Eosinophils Absolute Lymphocytes Absolute Monocytes Absolute Neutrophils Basophils Blasts Eosinophils Hematocrit (HCT) Hemoglobin (HB)

Hemoglobin electrophoresis

Lymphocytes Macrophages Mean corpuscular hemoglobin (MCH) Mean corpuscular hemoglobin concentration (MCHC) Mean corpuscular volume (MCV) Mean platelet volume (MPV) Metamylocytes Monocytes Myelocytes Neutrophils Platelet count Promyelocytes RBC Morphology

Red Blood Cell (RBC) Count

Red blood cell distribution width (RDW) Stab cells/Band cells/Band neutrophils WBC Morphology White Blood Cell (WBC) Count

General Comments Measured in % Measured in % Measured in % Measured in % Measured in % Measured in cells per microliter or % Measured in cells per microliter or % Measured in cells per microliter or % Measured in cells/mcL Measured in cells/mcL Hb A, Hb A2, Hb F, Hb S, Hb C measured in % Measured in platelets per microliter Measured in cells per microliter or %

Measured in gm/dL

Measured in %

Measured in femtoliter (fL) Measured in gm/dL Measured in cells per microliter or % Measured in cells per microliter or % Measured in cells per microliter or % Measured in femtoliter (fL) Measured as a count Measured in cells per microliter or % Measured in cells per microliter or % Measured in cells/mcL; for drug trials

Measured in %

Measured in cells per microliter or %

Measured in cells per microliter or % Measured in cells/mcL; for drug trials

Purpose Safety Safety Safety Safety Safety Safety Safety Safety Safety Safety

Classification Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental

Safety Supplemental

Safety Safety

Supplemental Supplemental

Safety Supplemental

Safety

Safety Safety Safety Safety Safety Safety Safety Safety Safety Safety

Safety

Supplemental

Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental

Supplemental

Safety

Safety Safety

Supplemental

Supplemental Supplemental

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Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (DMD) Common Data Elements (CDEs)

Table 2. Chemistries

CDE Alanine transaminase (ALT) Albumin Alkaline phosphatase (ALP) Amylase Anion gap Aspartate transaminase (AST) Bicarbonate Bilirubin, direct (conjugated) Bilirubin, total Blood urea nitrogen (BUN) Calcium Carbon dioxide Chloride

Creatine kinase

Ferritin Gamma glutamyl transferase (GGT) Glucose, fasting Glucose, random Ionized Calcium Iron

Lactate

Lactate dehydrogenase (LDH) Lipase Magnesium Phosphate

General Comments Measured in U/L Measured in g/dL Measured in IU/L Measured in U/L Ratio measured in mEq/L Measured in IU/L Measured in mmol/L (bicarbonate) Measured in mg/dL Measured in mg/dL Measured in mg/dL Measured in mg/dL Measured in mEq/L Measured in mEq/L

Measured in IU/L

Measured in ng/mL Measured in IU/L Measured in mg/dL Measured in mg/dL Measured in mg/dL Measured in mcg/dL

Measured in IU/L

Measured in IU/L Measured in IU/L Measured in mg/dL Measured in mg/dL

Potassium

Measured in mEq/L

Pre-Albumin Serum creatinine Sodium Total Iron Binding Capacity Total Protein Urate Urea-N Vitamin D

Measured in g/dL Measured in mg/dL Measured in mEq/L Measured in mcg/dL Measured in g/dL Measured in mol/L Measured in mmol/L Measured in ng/mL

Purpose Safety Safety Safety Safety Safety Safety Safety Safety Safety Safety Safety Safety Safety Diagnosis/ Outcome Safety Diagnosis Safety Safety Safety Safety Diagnosis/ Safety Safety Safety Diagnosis Safety Safety/ Diagnosis/ Outcome Safety Safety Safety Safety Safety Safety Safety Safety

Classification Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental

Supplemental

Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental

Supplemental

Supplemental Supplemental Supplemental Supplemental

Supplemental

Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental

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Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (DMD) Common Data Elements (CDEs)

Table 3. CSF

CDE Albumin, CSF Albumin index Cell count, CSF

CSF lactate CSF myelin basic protein (MBP) CSF PCR for viruses Cytopathology, CSF Differential, CSF Electrophoresis, Protein, CSF

Glucose, CSF IgG, CSF

IgG Index, CSF

Lyme Disease Ab, CSF

Protein, CSF

General Comments Measured in mg/dL. Major CSF protein component. Originates from blood. Measured in mg/dL. CSF to serum albumin ratio, x100. Reflects BBB permeability. Measured in cells/uL. WBC components. Predominantly mononuclears (lymphocytes, monocytes) but can also include neutrophils, eosinophils, plasma cells and other cells. Measured in mmol/L. CSF lactic acid level. Increased with tissue acidosis, anaerobic metabolism. Quantitative measure of detectable MBP like material in CSF. Virus nucleic acid (DNA or RNA) detection in CSF. Specialized technique to collect CSF cells with preserved morphology; used to detect malignant cells.

Measured in cells/uL.

Measured in mg/dL. Proteins are separated by electrophoresis to identify different fractions.

Measured in mg/dL. Measures glucose level in CSF; dependent on blood level (normally 60 to 80% of blood level)

Measured in mg/dL. Quantitative IgG level in CSF. Measured in mg/dL. Measures intrathecal IgG production. Derived from ratio of CSF IgG to CSF albumin compared to serum IgG to serum albumin ratio (quantitative abnormality). Positive; Negative. Immunoglobulin reactivity to B Burgdorferi. Measured by ELISA and/or Western blot. Measured in mg/dL. Measures total protein level in CSF predominantly albumin; reflects serum proteins with trace CNS components and intrathecal modified components.

Purpose Diagnosis/ Safety Diagnosis/ Safety Diagnosis/ Safety

Diagnosis

Diagnosis Outcome Diagnosis/ Safety Diagnosis/ Safety

Outcome

Diagnosis/ Safety

Diagnosis/ Safety

Diagnosis/ Safety

Outcome

Classification Supplemental Supplemental Supplemental

Supplemental Supplemental Supplemental Supplemental Supplemental Supplemental

Supplemental Supplemental

Supplemental

Supplemental

Supplemental

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Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (DMD) Common Data Elements (CDEs)

CDE Oligoclonal Banding, CSF

VDRL, CSF

Table 3. CSF, cont.

General Comments

Positive; Negative. Two or more discrete IgG electrophoretic bands in CSF not in serum. Reflects restricted intrathecal IgG production (qualitative abnormality). Positive; Negative. Nonspecific serologic test for syphilis; Venereal Disease Research Laboratory test is used to screen CSF for reagin antibodies diagnostic for neurosyphyilis.

Purpose Outcome

Diagnosis/ Safety

Classification Supplemental

Supplemental

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