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NameTR


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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.



Dataset2


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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




Info
titleQuestions 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 really 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.


Case 2 - Subject has AAA but TAA is not found

The subject had a MRI performed on the torso (trunk).Question:

Info
titleQuestions and Thoughts

I wonder what the LOC truly is in this procedure, or whether you need a value in PRLOC at all, because essentially, you are doing a Chest MRI, followed by abdominal MRI (or vise versa) - the MRI scans and take cross-sectional pictures of your chest and abdomen. If the scanning is done on the same day in one visit, would you consider the scan of the chest a separate procedure from the scan of the abdomen? This is why for "diagnostic procedures

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" procedure

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, I think the location where the procedure is done is irrelevant. When we say Chest CT, or Chest MRI, does this mean the CT scan is done on the chest (hence PRLOC), or does it mean that the purpose of the CT scan is to scan and create images of the chest, aka the thoracic region? I think this is where the confusion is

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 1  ABCPR  ABC-4561MRITrunkBASELINE



The MRI scan produced many cross-sectional images about the thoracic and abdominal regions of the subject. The evaluator then examined the MRI images of the thoracic region and abdominal region, and found the presence of a large AAA, but the absence of TAA.

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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 an positive record. It doesn't allow the creation of a "pertinent negative" record. If I were to model case 2 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. 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 as 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.

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NameTU


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



Dataset2


Row

STUDYID

DOMAIN

USUBJID

TUSEQ

TUGRPID

TULNKID

TUTEST

TUORRES

TULOC

TULAT

TUMETHOD

VISITNUM

VISIT

TUDTC

3ABCTUABC-45631Aneurysm 1Aneurysm Identification

Target?

Identified

Renal ArteryLeftMRI1BASELINE2020-04-27
5ABCTUABC-45652Aneurysm 2Aneurysm Location/Identification

Target?

Identified

Infrarenal Aorta
MRI1BASELINE2020-04-27



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