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Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

VISIT

 1  ABCPR  ABC-4561TRANSTHORACIC ECHOCARDIOGRAPHYBASELINE
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The transthoracic electrocardiography (TTE) produced images of the heart.

Rows 1-2:I examined the TTE image of the heart (test location) and found 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 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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Row

STUDYID

DOMAIN

USUBJID

TUSEQ

TUGRPID

TULNKID

TUTEST

TUORRES

TULOC

TUMETHOD

VISITNUM

VISIT

TUDTC


TURESLOCTURESLOC Detail
1ABCTUABC-45611CAL 1Calcification IndicatorYHEARTTRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27


2ABCTUABC-45621CAL 1Calcification Location/Identification

Target?

Identified

HEARTTRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27
Mitral Valve Annulus
3ABCTUABC-45632STEN 1Cardiac Valvular Stenosis IndicatorYHEARTTRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27


4ABCTUABC-45642STEN 1Cardiac Valvular Stenosis Location/Identification

Target?

Identified

HEARTTRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27
Mitral Valve
5ABCTUABC-45653REGUR 1Cardiac Valvular Regurgitation IndicatorYHEARTTRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27


6ABCTUABC-45663REGUR 1Cardiac Valvular Regurgitation Location/Identification

Target?

Identified

HEARTTRANSTHORACIC ECHOCARDIOGRAPHY1BASELINE2020-04-27
Mitral ValveInto the left atrium

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all paragraph and/or line breaks.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Row 1:I measured the diameter of the aneurysm in the left renal artery (test location).
Row 2:I measured the diameter of the aneurysm in the Infrarenal Aorta (test location).

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Row

STUDYID

DOMAIN

USUBJID

TRSEQTRLNKID

TRTEST

TRORRES

TRLOC

TRMETHOD

VISITNUM

VISIT

TRDTC

1ABCTRABC-4561CAL 1Calcification SeveritySevereMitral Valve AnnulusTTE1BASELINE2020-04-27
2ABCTRABC-4562STEN 1Cardiac Valvular Regurgitation SeveritySevereMitral ValveTTE1BASELINE2020-04-27
3ABCTRABC-4563REGUR 1Cardiac Valvular Stenosis SeverityModerateMitral ValveTTE1BASELINE2020-04-27
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

Row 1:An aneurysm is present in the left renal artery.
Row 2:An aneurysm is present in the Infrarenal Aorta

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Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKID

TUTEST

TUORRES

TULOC

TULAT

TUMETHOD

VISITNUM

VISIT

TUDTC

1ABCTUABC-4561Aneurysm 1Aneurysm Identification

Target

Renal ArteryLeftMRI1BASELINE2020-04-27
2ABCTUABC-4562Aneurysm 2Aneurysm IdentificationTargetInfrarenal Aorta
MRI1BASELINE2020-04-27

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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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Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

 1  ABCPR  ABC-1231CT SCANCHEST??? or not needed
BASELINE
2  ABCPR  ABC-1232CT SCANABDOMEN???? or not needed
BASELINE
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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.
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.
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.
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.
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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Row

STUDYID

DOMAIN

USUBJID

TUSEQ

TUGRPID

TULNKID

TUTEST

TUORRES

TULOC

TUMETHOD

VISITNUM

VISIT

TUDTC


TURESLOC
TURESLOC Detail
1ABCTUABC-12311Aneurysm 1Aneurysm IndicatorYThoracic region

CT SCAN

1BASELINE2020-04-27


2ABCTUABC-12321Aneurysm 1Aneurysm Location/Identification

Target?

Identified

Thoracic region

CT SCAN

1BASELINE2020-04-27
Thoracic AortaAortic Arch to Descending aorta
3ABCTUABC-12332Dissection 1Dissection IndicatorYThoracic region

CT SCAN

1BASELINE2020-04-27


4ABCTUABC-12342Dissection 1

Dissection Location/Identification

Target?

Identified

Thoracic region

CT SCAN

1BASELINE2020-04-27
Descending aorta
5ABCTUABC-12353Aneurysm 2Aneurysm IndicatorYAbdominal region

CT SCAN

1BASELINE2020-04-27


6ABCTUABC-12363Aneurysm 2Aneurysm Location/Identification

Target?

Identified

Abdominal region

CT SCAN

1BASELINE2020-04-27
Infrarenal aortaproximal to the iliac bifurcation
7ABCTUABC-12374Dissection 2Dissection IndicatorYAbdominal regionCT SCAN1BASELINE2020-04-27


8ABCTUABC-12384Dissection 2

Dissection Location/Identification

Target?

Identified

Abdominal region

CT SCAN

1BASELINE2020-04-27
Infrarenal aortaproximal to the iliac bifurcation

Dataset Debug Messages

  • There are two leading, trailing, or non-breaking spaces in the dataset.
  • Please remove all paragraph and/or line breaks.
  • Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Row 1:I measured the diameter of the aneurysm from aortic arch to the descending aorta (test location).
Row 2: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.

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Row

STUDYID

DOMAIN

USUBJID

TRSEQ

TRLNKID

TRTEST

TRORRES

TRORRESU

TRLOC

TRLOCDTL

TRMETHOD

VISITNUM

VISIT

CVDTC

1ABCTRABC-1231Aneurysm 1Aneurysm Diameter6cmThoracic AortaAortic Arch to Descending aortaCT SCAN1BASELINE2020-04-27
2ABCTRABC-1232Aneurysm 2Aneurysm Diameter7cmInfrarenal aortaproximal to the iliac bifurcationCT SCAN1BASELINE2020-04-27
4ABCTRABC-1233Dissection 1Stanford AoD ClassificationStanford B
Descending aorta
CT SCAN1BASELINE2020-04-27
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Questions and Thoughts

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.

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