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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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| Dataset2 |
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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 transthoracic electrocardiography (TTE) produced images of the heartbelow examples show the identification of calcification in the mitral valve annulus as well as mitral valve stenosis (TU). It also shows mitral valve regurgitation (CV).
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| Rows 1-23: | I examined the TTE image Examination of the heart (test location) and found indicates calcified mitral valve annulus (result location). | Row 3-4: | I examined the TTE image of the heart (test location) and found that the mitral valve (result location) had become stenoticstenosis. |
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| Rows 4-5-6: | I examined the TTE image Examination of the heart (test location) and regurgitation of blood in indicates regurgitation at the mitral valve back , blood is regurgitating from the left ventricle into the left atrium. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ |
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TUGRPIDTULNKID| TUTESTCD | TUTEST | TULOC | TUORRES |
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| TUSTRESC | TURESLOC | TURESLOC Detail |
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TULOC | TUMETHOD | VISITNUM | VISIT | TUDTC |
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TURESLOCTURESLOC Detail | 1CAL 1 | Calcification IndicatorHEART |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 2 | ABC | TU | ABC-456 | 2 |
1CAL 1 | Calcification Location/Identification | Target? | ABNEXAM | Examination for Abnormality |
IdentifiedTRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27| Valvular Calcification | Valvular Calcification | Mitral Valve Annulus |
3 | ABC | TU | ABC-456 | 3 | 2 | STEN 1 | Cardiac Valvular Stenosis Indicator | YHEART |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
442STEN 1 | Cardiac Valvular Stenosis Location/Identification | Target? Identified| ABNEXAM | Examination for Abnormality | HEART |
TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | Mitral Valve | 5 | ABC | TU | ABC-456 | 5 | 3 | REGUR 1 | Cardiac Valvular Regurgitation Indicator | Y | HEART | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | 6 | ABC | TU | ABC-456 | 6 | 3 | REGUR 1 | Cardiac Valvular Regurgitation Location/Identification | Target? Identified | | Valvular Stenosis | Valvular Stenosis | Mitral Valve |
HEART |
| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
Mitral Valve | Into the left atrium
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| Row 1: | I measured the diameter of the aneurysm in the left renal artery (test location). |
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Row 2: | I measured the diameter of the aneurysm in the Infrarenal Aorta (test location). |
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| TRSEQ | TRLNKID | TRTEST | TRORRES | TRLOC | TRMETHOD | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVSTRESC | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT |
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TRDTCTRCAL 1 | Calcification Severity | Severe | Mitral Valve Annulus | TTE |
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| Abnormality Indicator | HEART | Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 2 | ABC |
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TRSTEN 1 | Cardiac Valvular Regurgitation Severity | Severe | Mitral Valve | TTE | 1 | BASELINE | 2020-04-27 | 3 | ABC | TR | ABC-456 | 3 | REGUR 1 | Cardiac Valvular Stenosis Severity | Moderate | Mitral Valve | TTE| 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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The problem with the way TU is set up now, which is originally designed for tumor identification and response evaluation, and you only care about "already identified tumors", is that it only allows the creation of only positive records. It doesn't allow the creation of a "pertinent negative" record. If I were to model case 1 in TU the way TU is designed now, I would lose the ability to represent the negative record for the Thoracic Region as shown above because an aneurysm is not identified in this region. The locations where an aneurysm is found, are mapped to TULOC instead of TURESLOC. Because when a large AAA is found, the chance of a TAA (or an aneurysm developed elsewhere) is high (the reverse holds true as well), in the presence of a diagnosed large AAA or TAA, it is recommended to also screen for the other. A TAA is synchronous if diagnosed within 2 years from the diagnosis of an AAA. All TAAs diagnosed at a later date were considered metachronous and must have had prior chest imaging that did not show the presence of TAA.
In the original DUKE data element, the responses provided for TAA and AAA, and all other types of aneurysms all have the responses: present, absent and unknown.Alternatively modeling all of the above in CV:
An evaluator examines the images of the thoracic and abdominal regions produced by the CT scan and decides whether TAA and AAA are present as well as their location. Note for viewing simplicity, some variables are omitted from the table below.
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| Row Rows 1: | An aneurysm is present in the left renal artery. |
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| Row 2: | An aneurysm is present in the Infrarenal Aorta |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTEST | TUORRES | TULOC | TULAT | TUMETHOD | VISITNUM | VISIT | TUDTC |
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| 1 | ABC | TU | ABC-456 | 1 | Aneurysm 1 | Aneurysm Identification | Target | Renal Artery | Left | MRI | 1 | BASELINE | 2020-04-27 |
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2 | ABC | TU | ABC-456 | 2 | Aneurysm 2 | Aneurysm Identification | Target | Infrarenal Aorta | MRI | 1 | BASELINE | 2020-04-27 |
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Case 2 - Subject has both TAA and AAA
The subject had a chest CT scan and an abdominal CT scan.
Are chest and abdomen really location of the procedure? See questions and comments under case 1
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| -4: | Examination of the heart indicates calcified mitral valve annulus and mitral 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. |
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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. |
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| Rows 1-2: | I examined the image of the thoracic region (test location) and found an aneurysm in the Thoracic Aorta (result location) spanning from the aortic arch to the descending aorta (result location detail). In this case result location detail further qualifies both ORRES and RESLOC, hence this is a variable qualifier. |
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| Rows 3-4: | I examined the image of the thoracic region (test location) and found that the descending aorta (result location) had dissected (the artery is tore and a false lumen had formed), most likely due to the enormous pressure caused by the large aneurysm in this area. |
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| Rows 5-6: | I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (result location), proximal to the iliac bifurcation (result location detail). In this case result location detail is a variable qualifier for the result, I am trying to say that the aneurysm is located in the segment of the infrarenal aorta closer (proximal) to the iliac bifurcation. |
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| Rows 7-8: | I examined the image of the abdominal region (test location) and found that the infrarenal aorta (result location) had dissected. |
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| Dataset2 |
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| TUSEQ | TUGRPID | TULNKID | TUTEST | TUORRES | TULOC | TUMETHOD | CVSEQ | CVLNKID | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVSTRESC | CVSTRESN | CVRESLOC | CVRESLOC Detail | CVMETHOD | VISITNUM | VISIT |
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TUDTC | TURESLOC
| TURESLOC Detail | TU1231 | Aneurysm 1 | Aneurysm Indicator
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| ABNIND | Abnormality Indicator | HEART | Y | Y |
Thoracic region | CT SCAN| Y |
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| TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 | | 2 | ABC |
TU1231 | Aneurysm 1 | Aneurysm Location/Identification | Target? Identified | Thoracic region | |
| mv | ABNEXAM | Examination for Abnormality | HEART | Valvular Calcification | Valvular Calcification | Valvular Calcification | Mitral Valve Annulus |
| TRANSTHORACIC ECHOCARDIOGRAPHY |
CT SCANThoracic Aorta | Aortic Arch to Descending aortaTU1232 | Dissection 1 | Dissection Indicator | Y | Thoracic region | | 1 | mv | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Valvular Stenosis | Mitral Valve |
| TRANSTHORACIC ECHOCARDIOGRAPHY |
CT SCANTU123Dissection 1 | Dissection Location/Identification | Target? Identified | Thoracic region | | mv | ABNEXAM | Examination for Abnormality | HEART | Blood Regurgitation | Blood Regurgitation | Blood Regurgitation | Mitral Valve | From left ventricle into the left atrium | TRANSTHORACIC ECHOCARDIOGRAPHY |
CT SCANDescending aortaTU1233 | Aneurysm 2 | Aneurysm Indicator | Y | Abdominal region | |
| av | ABNEXAM | Examination for Abnormality | HEART | Flail Cusp | Flail Cusp | Flail Cusp | Aortic Valve, Right Coronary Cusp |
| TRANSTHORACIC ECHOCARDIOGRAPHY |
CT SCANTU123Aneurysm 2 | Aneurysm Location/Identification | Target? Identified | Abdominal region | | av | ABNEXAM | Examination for Abnormality | HEART | Valvular Stenosis | Valvular Stenosis | Valvular Stenosis | Aortic Valve |
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CT SCANInfrarenal aorta | proximal to the iliac bifurcationTU123Dissection 2Dissection Indicator | Y | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 | 8 | ABC | TU | ABC-123 | 8 | 4 | Dissection 2 | Dissection Location/Identification | Target? Identified | Abdominal region | CT SCAN | | ABNEXAM | Examination for Abnormality | HEART | Blood Regurgitation | Blood Regurgitation | Blood Regurgitation | Aortic Valve | From aorta to left ventricle | TRANSTHORACIC ECHOCARDIOGRAPHY | 1 | BASELINE | 2020-04-27 |
Infrarenal aorta | proximal to the iliac bifurcation |
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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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I measured the diameter of the aneurysm from aortic arch to the descending aorta (test location)| Mitral valve stenosis is moderate. | | Row 2: |
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I measured the diameter of the infrarenal aortic (test location) aneurysm. | Row 3: | The dissected descending aorta (test location) is classified based on the Stanford Aortic Dissection System as type B| Mitral valve regurgitation is moderate. | | Rows 3-4: | Aortic valve regurgitation and stenosis are mild. |
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TRSEQTRLNKIDTRTESTTRORRES | TRORRESU | TRLOC | TRLOCDTL | TRMETHOD| RSCAT | RSORRES | VISITNUM | VISIT |
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CVDTCTR123Aneurysm Aneurysm Diameter | 6 | cm | Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | | VSC-Cardiac Valvular Stenosis Severity: Mitral Valve | VALVE STENOSIS CLASSIFICATION 2009 VERSION | Moderate | 1 | BASELINE | 2020-04-27 | | 2 | ABC |
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TR123Aneurysm Aneurysm Diameter | 7 | cm | Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | | SNVRC-Cardiac Valvular Regurgitation Severity: Mitral Valve | SEVERITY OF NATIVE VALVULAR REGURGITATION CLASSIFICATION 2003 | Moderate | 1 | BASELINE | 2020-04-27 |
4TR123Dissection 1 | Stanford AoD Classification | Stanford B | Descending aorta | | 3 | VSC-Cardiac Valvular Stenosis Severity: Aortic Valve | VALVE STENOSIS CLASSIFICATION 2009 VERSION | Mild |
CT SCAN |
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| title | Questions and Thoughts |
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The results for TU, TUORRES = target, non-target, or new target. This convention was designed for tumor assessment. Target and non-target have very specific definitions depending on the tumor under study. Generally for solid tumor, according to RECIST: Measurable lesions - lesions that can be accurately measured in at least one dimension with longest diameter 20 mm using conventional techniques or 10 mm with spiral CT scan. - All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.
Non-measurable lesions - all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques. - All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout follow-up.
Since TU is also shared by Lesion Identification, to have a result as "target" is misleading and doesn't always apply to non-tumor settings. When you say there is a target aneurysm, what does that mean? Target for treatment and response evaluation? what is the criteria that makes it a target? Usually an aneurysm larger than 5cm requires surgery. Does that mean the ones that are smaller than 5 cm are considered "non-target"? and non-target for what? surgery not needed? The values for TU responses right now, doesn't make sense for non-tumor lesion identification process. |
After all this, i struggle with what values should go into TULOC. When a CT scans the chest, it produces cross-sectional images of the thorax. You can view the images in three angles: axial view (you are looking at the picture of the thorax from the direction of head to toe), the coronal view (you are looking at the images of the thorax as if you are standing in front of the person), sagittal view (you are looking at the picture of the thorax from the side). Hence TULOCs are populated with Thoracic Region and Abdominal Region. Especially in the axial view, as you move from cross-sectional images of the thorax to images of the abdomen, you are looking at sectioned images of the thoracic region to abdominal region, there is no mistake about it.
| ABC | RS(CC) | ABC-456 | 4 | 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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