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| title | TU Domain Definition and Scope |
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The Tumor/Lesion domains (TU, TR) represent data collected in clinical trials where sites of disease (e.g., tumors/lesions/locations of interest, lymph nodes, organs of interest in the assessment of the disease) are identified and then repeatedly measured/assessed at subsequent time points and often used in an evaluation of disease response(s). Tumor/Lesion Identification (TU) |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | VISIT |
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| 1 | ABC | PR | ABC-456 | 1 | TRANSTHORACIC ECHOCARDIOGRAPHY | BASELINE |
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The below example shows examples show the identification of calcification in the mitral valve annulus as well as mitral valve stenosis (TU). It also shows mitral valve regurgitation . Technically, regurgitation is not considered as a lesion, however it is the direct result of the lesion (mitral valve stenosis/narrowing and structural change, caused by the annular calcification). Should this be mapped to TU as well? I suppose you could consider this as a site of disease, specifically locations of interest where you identify then repeatedly assess?
Agreed modeling approach allows us to represent the variety of lesions and abnormal findings associated with said lesions into TUORRES. It also allows us to represent other abnormal findings associated with that lesion.
(CV).
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| Rows 1-3: | Examination of the heart indicates calcified mitral valve annulus and mitral valve stenosis. |
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| Rows 4-5: | Examination of the heart indicates regurgitation at the mitral valve, blood is regurgitating from the left ventricle into the left atrium. |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TULOC | TUORRES | TUSTRESC | TURESLOC | TURESLOC Detail | TUMETHOD | VISITNUM | VISIT | TUDTC |
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| 1 | ABC | TU | ABC-456 | 1 |
| LESIONIND | Lesion IndicatorPathological Finding Indicator Abnormality Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 2 | ABC | TU | ABC-456 | 2 | mv calcification 1 | ABNEXAM | Examination for Abnormality | HEART | Valvular Calcification | Valvular Calcification | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 3 | ABC | TU | ABC-456 | 3 | mv stenosis 1 | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Mitral Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 4 |
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVSTRESC | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT | TUDTC |
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| 1 | ABC |
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TU4 | This is not a lesion so we can't use lesion indicator | Cardiac Valvular Regurgitation Indicator Pathological Finding Indicator Abnormality Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
5TU5regurgitation 1| mv regurgitation | ABNEXAM | Examination for Abnormality | HEART | Blood Regurgitation | Blood Regurgitation | Mitral Valve | From left ventricle into the left atrium | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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Alternatively modeling
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all of the above in CV:
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| Rows 1-24: | I examined the TTE image Examination of the heart (test location) and found indicates calcified mitral valve annulus (result location)and mitral valve stenosis, as well as regurgitation. |
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| Rows 35-48: | Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS. |
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| Rows 9-11: | Examination of the heart indicates flail aortic cusp and aortic valve stenosis, as well as regurgitation. |
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| Rows 5-8: | Show the various measurements of the regurgitant jet, which are used for the MV regurgitation severity assessment in RS | I examined the TTE image of the heart (test location) and found that the mitral valve (result location) had become stenotic. | Rows 5-6: | I examined the TTE image of the heart (test location) and regurgitation of blood in the mitral valve back into the left atrium. |
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| TUSEQ | TUGRPID | TULNKID | TUTEST | TULOC | TUORRES | TURESLOC | TURESLOC Detail | TUMETHOD | CVSEQ | CVLNKID | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVSTRESC | CVSTRESN | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT |
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TUDTCTU1CAL 1Calcification IndicatorHEART| Y | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 2 | ABC |
TU1 | CAL 1 | Calcification Location Identification | HEART | identified |
| mv | ABNEXAM | Examination for Abnormality | HEART | Valvular Calcification | Valvular Calcification | Valvular Calcification | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 3 | ABC |
TU2 | STEN 1 | Cardiac Valvular Stenosis Indicator | HEART | | 1 | mv | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Valvular Stenosis | Mitral Valve |
Y |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 4 | ABC |
TUSTEN 1 | Cardiac Valvular Stenosis Location Identification | HEART | identified | | mv | ABNEXAM | Examination for Abnormality | HEART | Blood Regurgitation | Blood Regurgitation | Blood Regurgitation | Mitral Valve | From left ventricle into the left atrium |
Mitral Valve | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 5 | ABC |
TU3REGUR 1 | Cardiac Valvular Regurgitation Indicator| ABNEXAM | Examination for Abnormality | HEART |
| Flail Cusp | Flail Cusp | Flail Cusp | Aortic Valve, Right Coronary Cusp |
Y |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 6 | ABC |
TUREGUR 1 | Cardiac Valvular Regurgitation Location Identification | HEART | identified | Mitral Valve | | av | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Valvular Stenosis | Aortic Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 7 | ABC | CV | ABC-456 | 7 | 4 | av | ABNEXAM | Examination for Abnormality | HEART | Blood Regurgitation | Blood Regurgitation | Blood Regurgitation | Aortic Valve | From aorta to left ventricle |
Into the left atrium | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
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The following example shows how to model severity assessments of the identified lesions and abnormalities based on peer-reviewed, validated and published instruments (either copyrighted or public domain). Note these tests were originally created as a CVTESTs, if users are using SDTMIG versions prior to 3.4. Per SDTMIG 3.4, this is now considered as a grading scale and therefore should now be represented as CC/RS.
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| Row 1: | Mitral valve stenosis is moderate. |
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| Row 2: | Mitral valve regurgitation is severemoderate. |
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| Rows 3-4: | Aortic valve regurgitation and stenosis are mild. |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTEST | RSCAT | RSORRES | VISITNUM | VISIT | RSDTC |
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| 1 | ABC | RS(CC) | ABC-456 | 1 | REGUR 1 | VSC-Cardiac Valvular Stenosis Severity: Mitral Valve | VALVE STENOSIS CLASSIFICATION 2009 VERSION | Moderate | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | RS(CC) | ABC-456 | 2 | STEN 12 | SNVRC-Cardiac Valvular Regurgitation Severity: Mitral Valve | SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003 | SevereModerate | 1 | BASELINE | 2020-04-27 |
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The below example shows how to represent calcification severity from a sponsor defined criteria using the TR domain. The Mitral Valve Annulus identified in TU is severely calcified.
| 3 | ABC | RS(CC) | ABC-456 | 3 | 3 | VSC-Cardiac Valvular Stenosis Severity: Aortic Valve | VALVE STENOSIS CLASSIFICATION 2009 VERSION | Mild | 1 | BASELINE | 2020-04-27 |
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| 4 | ABC | RS(CC) |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | TRLNKID | TRTEST | TRCAT | TRORRES | VISITNUM | VISIT | RSDTC |
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1 | ABC | TR1CAL 1 | Calcification Severity | Sponsor-defined Criteria | Severe| 4 | SNVRC-Cardiac Valvular Regurgitation Severity: Aortic Valve | SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003 | Mild | 1 | BASELINE | 2020-04-27 |
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