CDE Detailed Report

Disease: Myasthenia Gravis
Sub-Domain: Laboratory Tests and Biospecimens/Biomarkers
CRF: Skin Biopsies for Qualification of Intraepidermal Nerve Fibers

Displaying 1 - 28 of 28
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C12234 Preservation technique used amount value PresrvtnTechnqUseAmntVal Value of the amount of preservation solution or material used to preserve the specimen Value of the amount of preservation solution or material used to preserve the specimen Amount Alphanumeric

Answer for the freezing or fixation technique used. Answer should be recorded in milligrams (mg). If amount used is not known, select Not known.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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milligram
C12293 Tissue specimen intraepidermal nerve fiber density value TisIntraepdrmlNrvFibrDnsityVal Value of the intraepidermal nerve fiber density in the tissue specimen Value of the intraepidermal nerve fiber density in the tissue specimen Intraepidermal nerve fiber density Numeric Values

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C12235 Histochemical stains used type HistchmclStainUseTyp Type of standard histochemical stains used on the tissue specimen Type of standard histochemical stains used on the tissue specimen Which standard histochemical stains were used? H and E;anti-PGP 9.5;Other, specify H and E;anti-PGP 9.5;Other, specify Alphanumeric

Choose all that apply

No references available Adult;Pediatric Core 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Multiple Pre-Defined Values Selected

C12294 Laboratory pathology normal range LabPatholNrmlRng Range of intraepidermal nerve fiber density that is considered normal at the pathology laboratory examining the tissue specimen Range of intraepidermal nerve fiber density that is considered normal at the pathology laboratory examining the tissue specimen Normal range for this laboratory Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C12247 Biopsy and Autopsy tissue collection method type BpApTissCollMethdTyp The type of method used for collection of the tissue specimen The type of method used for collection of the tissue specimen Method of tissue collection Punch biopsy;Blister biopsy;Open biopsy Punch biopsy;Blister biopsy;Open biopsy Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C12295 Laboratory pathology normal range age match indicator LabPatholNrmlRngAgeMatchInd Indicator of whether the pathology laboratory's normal range of intraepidermal nerve fiber density is age-matched to the patient from whom the tissue specimen was taken Indicator of whether the pathology laboratory's normal range of intraepidermal nerve fiber density is age-matched to the patient from whom the tissue specimen was taken Is the normal range approximately age-matched to the patient Yes;No;Unknown Yes;No;Unknown Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C12285 Tissue specimen collection anatomic site TissSpecmnCollAntmicSite Anatomic site from which the tissue specimen was collected Anatomic site from which the tissue specimen was collected Site of tissue collection 10cm above lateral malleolus;Other, specify 10cm above lateral malleolus;Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C12296 Tissue specimen sweat gland innervation evaluate indicator TissSpcmnSwtGlndInnrvtnEvalInd Indicator of whether sweat gland innervation was evaluated for the tissue specimen Indicator of whether sweat gland innervation was evaluated for the tissue specimen Was sweat gland innervation evaluated? Yes;No;Unknown Yes;No;Unknown Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C12226 Specimen source type SpecmnSourcTyp Type of specimen collection source Type of specimen collection source Is this a biopsy or autopsy specimen? Biopsy;Autopsy Biopsy;Autopsy Alphanumeric

No instructions available

No references available Adult;Pediatric Core 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C12286 Tissue specimen section thickness measurement TissSpecmnSectnThickMeasr Measurement in microns of the thickness of the section taken from the tissue specimen Measurement in microns of the thickness of the section taken from the tissue specimen Section Thickness Unknown Unknown Alphanumeric

If thickness is not known, select Not known.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

micron
C17908 Tissue specimen intraepidermal nerve fiber statistics other report text TissSpecmnIENFStatsOthrRptText Text description of any other intraepidermal nerve fiber (IENF) statistics that were reported for the tissue specimen by the pathology laboratory Text description of any other intraepidermal nerve fiber (IENF) statistics that were reported for the tissue specimen by the pathology laboratory Other reported IENF Statistics Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C12227 Postmortem interval for autopsy specimen value PstmrtmIntrvlApSpecmnVal Interval in hours of time elapsed between death and the autopsy at which the tissue specimen was collected Interval in hours of time elapsed between death and the autopsy at which the tissue specimen was collected If this is an autopsy specimen, what is the approximate postmortem interval? Numeric Values

Only answered if "Autopsy" is answered for "Is this a biopsy or autopsy specimen?"

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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hour
C12287 Tissue specimen section count TissSpecmnSectnCt Count of the number of sections from the tissue specimen that were taken and evaluated Count of the number of sections from the tissue specimen that were taken and evaluated Number of sections quantified Unknown Unknown Alphanumeric

If number of sections is not known, then select Not known.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C17909 Tissue specimen comment other text TissSpecmnCommentOtherText Text description of any other comments pertaining to the pathology examination of the tissue specimen Text description of any other comments pertaining to the pathology examination of the tissue specimen Other comments Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C12229 Tissue specimen size measurement TissSpecmnSizeMeasr Measurement of the size of the tissue specimen collected Measurement of the size of the tissue specimen collected Size of tissue collected Numeric Values

Answer should be recorded as a dimension (AAxAAxAA) in centimeters (cm).

No references available Adult;Pediatric Core 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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centimeter
C12288 Tissue specimen section microscopy type TissSpecmnSectnMicroscpyType Type of microscopy used to view the sections taken from the tissue specimen Type of microscopy used to view the sections taken from the tissue specimen Microscopy technique Brightfield;Fluorescence Brightfield;Fluorescence Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C18828 Histochemical stains used other text HistchmclStainUseOTH The free-text field related to 'Histochemical stains used type' specifying other text. Type of standard histochemical stains used on the tissue specimen The free-text field related to 'Histochemical stains used type' specifying other text. Type of standard histochemical stains used on the tissue specimen Other, specify Alphanumeric

Choose all that apply

No references available Adult;Pediatric Core 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 4000

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C12230 Tissue specimen collection date and time TissSpecmnCollctnDateTime Date (and time if applicable and known) when the tissue specimen was collected Date when the tissue specimen was collected Date of tissue collection Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

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C12289 Tissue specimen section quantify type TissSpecmnSectnQuantfyTyp Type of quantification used in evaluating the sections taken from the tissue specimen Type of quantification used in evaluating the sections taken from the tissue specimen Quantification method used Manual counting;Stereology;Computer-assisted;Other, specify Manual counting;Stereology;Computer-assisted;Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C18830 Tissue specimen collection anatomic site other text TissSpecmnCollAntmicOTH The free-text field related to 'Tissue specimen collection anatomic site' specifying other text. Anatomic site from which the tissue specimen was collected The free-text field related to 'Tissue specimen collection anatomic site' specifying other text. Anatomic site from which the tissue specimen was collected Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Core 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 4000

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C12231 Laboratory name LabName Name of laboratory where assessment was performed Name of laboratory where assessment was performed Name of Laboratory where pathology was performed Alphanumeric

Record the laboratory name where pathology was performed

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C12290 Tissue specimen section quantify volume normalize type TissSpecmnSectnQuantVolNormTyp Type of method used to normalize the volume of the tissue specimen Type of method used to normalize the volume of the tissue specimen Method for normalizing specimen volume Section length;Using grid;Other, specify;Not known Section length;Using grid;Other, specify;Not known Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C18831 Tissue specimen section quantify other text TissSpecmnSectnQuantfyOTH The free-text field related to 'Tissue specimen section quantify type' specifying other text. Type of quantification used in evaluating the sections taken from the tissue specimen The free-text field related to 'Tissue specimen section quantify type' specifying other text. Type of quantification used in evaluating the sections taken from the tissue specimen Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 4000

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C12232 Laboratory director name LabDirectorName Name of laboratory director where assessment was performed Name of laboratory director where assessment was performed Name of Laboratory Director Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 255

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C12291 Tissue specimen counting threshold type TissSpcmnSctnQuantCtThrshldTyp Type of threshold for counting in the tissue specimen Determining if all immunoreactive profiles counted, or only nerve fibers that cross the dermal/epidermal border Threshold for counting All immunoreactive profiles;Only nerves crossing the dermal/epidermal border All immunoreactive profiles (including nerve fragments);Only nerves crossing the dermal/epidermal border Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C18832 Tissue specimen section quantify volume normalize other text TissSpecmnSectnQuantVolNormOTH The free-text field related to 'Tissue specimen section quantify volume normalize type' specifying other text. Type of method used to normalize the volume of the tissue specimen The free-text field related to 'Tissue specimen section quantify volume normalize type' specifying other text. Type of method used to normalize the volume of the tissue specimen Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations 4000

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C12233 Preservation technique used type PresrvtnTechnqUseTyp Type of preservation technique used to preserve the specimen Type of preservation technique used to preserve the specimen Freezing or Fixation Used? Zamboni's solution-fixed;Parformaldehyde-fixed;Formalin-fixed;Frozen Zamboni's solution-fixed;Parformaldehyde-fixed;Formalin-fixed;Frozen Alphanumeric

Choose only one

No references available Adult;Pediatric Core 3.00 2013-07-24 11:38:01.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

C12292 Tissue specimen Langerhans cell process result type TissSpcmnLngrhnsCelProcRsltTyp Result for the number of Burden of Langerhans cell processes in the tissue specimen Result for the number of Burden of Langerhans cell processes in the tissue specimen Burden of Langerhans cell processes Low;Moderate;High;Not known Low;Moderate;High;Not known Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Skin Biopsies for Qualification of Intraepidermal Nerve Fibers Laboratory Tests and Biospecimens/Biomarkers Assessments and Examinations

Single Pre-Defined Value Selected

CSV