CDE Detailed Report
Disease: Congenital Muscular Dystrophy
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: Skin Biopsies for Qualification of Intraepidermal Nerve Fibers
Displaying 1 - 30 of 30
Subdomain Name: Laboratory Tests and Biospecimens/Biomarkers
CRF: Skin Biopsies for Qualification of Intraepidermal Nerve Fibers
Displaying 1 - 30 of 30
| CDE ID | CDE Name | Variable Name | Definition | Short Description | 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 / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C58650 | Tissue specimen section thickness not known indicator | TissSpecSectnThickNotKnowInd | Indicator that the tissue specimen thickness is not known | Indicator that the tissue specimen thickness is not know | Section Thickness | Unknown | Unknown | Alphanumeric | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2019-11-20 11:42:55.0 | Skin Biopsies for Qualification of Intraepidermal Nerve Fibers | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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| C58651 | Tissue specimen section count unknown indicator | TissSpcmnSectnCtUnknwnInd | Indicator that the count of tissue speciments is unknown | Indicator that the count of tissue speciments is unknow | Number of sections quantified | Unknown | Unknown | Alphanumeric | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2019-11-20 12:00:11.0 | Skin Biopsies for Qualification of Intraepidermal Nerve Fibers | Laboratory Tests and Biospecimens/Biomarkers | Assessments and Examinations |
Single Pre-Defined Value Selected |
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| 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 | Supplemental-Highly Recommended | 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 |
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| 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 | Numeric Values |
If thickness is not known, select Not known. |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 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 |
Free-Form Entry |
microns | |||||||||
| 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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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 | Numeric Values |
If number of sections is not known, then select Not known. |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 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 |
Free-Form Entry |
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| 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 |
Free-Form Entry |
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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 | 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 |
Free-Form Entry |
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 |
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| 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 | 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 |
Free-Form Entry |
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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 | 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 |
Free-Form Entry |
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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 |
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| 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 |
Supplemental - Highly Recommended for CMD |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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| 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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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| 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 |
Free-Form Entry |
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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 | 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 |
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| 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 |
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| 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 |
Free-Form Entry |
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 |
Free-Form Entry |
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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 | 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 |
Multiple Pre-Defined Values Selected |
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| 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 |
Free-Form Entry |
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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 |
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| 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 |
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| 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 |
Supplemental - Highly Recommended for CMD |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 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 |
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| 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 |
