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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.
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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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| title | cv.xpt |
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| Name | PR |
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STUDYID
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DOMAIN
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USUBJID
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PRTRT
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VISIT
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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.
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| title | cv.xpt |
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| Name | TU |
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STUDYID
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DOMAIN
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USUBJID
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TUGRPID
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TUTEST
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TUORRES
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TULOC
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TUMETHOD
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VISITNUM
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VISIT
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TUDTC
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CT SCAN
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Target?
Identified
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CT SCAN
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CT SCAN
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Dissection Location/Identification
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Target?
Identified
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CT SCAN
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CT SCAN
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Target?
Identified
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CT SCAN
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Dissection Location/Identification
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Target?
Identified
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CT SCAN
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STUDYID
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DOMAIN
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USUBJID
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TRLNKID
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TRTEST
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TRORRES
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TRLOC
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TRMETHOD
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VISITNUM
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VISIT
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CVDTC
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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.
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.
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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