The below concept map shows the impact of creating a separate non-tumor lesion domain (which uses the original tumor domain structure) and how it affects modeling:
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| Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention |
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| Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention |
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Example 1: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is not treated and continuously monitored.
| Dataset wrap |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRLOC | VISIT |
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| 1 | ABC | PR | ABC-123 | 1 | CT SCAN | ABDOMEN | BASELINE |
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...
| Dataset wrap |
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| Dataset2 |
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| hi3 | TURESLOC |
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| hi2style | yellow |
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| hi3style | BOLD |
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ROW | STUDYID | DOMAIN | USUBJID | CVSEQ | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVCAT | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
| CVTUFLAG |
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| 1 | ABC | CV | ABC-123 | 1 | AR | ABNIND | Abnormality Indicator | Abdominal region | NON-TARGET FOR STUDY TREATMENT (MONITORING) | Y |
| Y | Y |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 2 | ABC | CV | ABC-123 | 2 | AR-Aneurysm | ABNEXAM | Examination for Abnormality | Abdominal region | NON-TARGET FOR STUDY TREATMENT (MONITORING) | Aneurysm |
| Aneurysm | Aneurysm |
| Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 3 | ABC | CV | ABC-123 | 3 | AR-Aneurysm | LENGTH | Length |
| NON-TARGET FOR STUDY TREATMENT (MONITORING) | 2 | cm | 2 | 2 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| | 4 | ABC | CV | ABC-123 | 4 | AR-Aneurysm | MAXLDIA | Maximal Luminal Diameter |
| NON-TARGET FOR STUDY TREATMENT (MONITORING) | 2.5 | cm | 2.5 | 2.5 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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| Nsvmeta |
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| Variable | Label | Type | Role | Origin |
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| CVTUFLAG | Flag for TU, TR or RS Data | text | Non-Standard Record Qualifier | CRF |
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Example 2: Observed abnormality that's also a lesion and "target" for study intervention
The subject had a chest CT scan.
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| Dataset wrap |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | VISITNUM | VISIT | TUDTC |
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| 1 | ABC | TR | ABC-123 | 1 | TR-Aneurysm | LENGTH | Length | 4 | cm | 4 | 4 | cm | cm | BASELINE | 2020-04-27 |
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| 2 | ABC | TR | ABC-123 | 2 | TR-Aneurysm | MAXLDIA | Maximal Luminal Diameter | 5 | cm | 5 | 5 | cm | cm | BASELINE | 2020-04-27 |
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| 3 | ABC | TR | ABC-123 | 3 | TR-Aneurysm | LENGTH | Length | 2 | cm | 2 | 2 | cm | cm | VISIT 2 | 2020-05-27 |
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| 4 | ABC | TR | ABC-123 | 4 | TR-Aneurysm | MAXLDIA | Maximal Luminal Diameter | 3 | cm | 3 | 3 | cm | cm | VISIT 2 | 2020-05-27 |
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Example 3: what the data should look like if there aren't separate non-tumor lesion domains, whether or not the aneurysm is treated with a study intervention. Pretend there are no TU/TR.
| Dataset wrap |
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| Dataset2 |
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| hi3 | TURESLOC |
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| hi2style | yellow |
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| hi3style | BOLD |
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ROW | STUDYID | DOMAIN | USUBJID | CVSEQ | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVCAT | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
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| 1 | ABC | CV | ABC-123 | 1 | TR | ABNIND | Abnormality Indicator | Thoracic Region | TARGET FOR STUDY TREATMENT | Y |
| Y | Y |
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| CT SCAN | 1 | BASELINE | 2020-04-27 | | 2 | ABC | CV | ABC-123 | 2 | TR-Aneurysm | ABNEXAM | Examination for Abnormality | Thoracic Region | TARGET FOR STUDY TREATMENT | Aneurysm |
| Aneurysm | Aneurysm |
| Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | 1 | BASELINE | 2020-04-27 | | 3 | ABC | CV | ABC-123 | 3 | AR | ABNIND | Abnormality Indicator | Abdominal region | NON-TARGET FOR STUDY TREATMENT (MONITORING) | Y |
| Y | Y |
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| CT SCAN | 1 | BASELINE | 2020-04-27 | | 4 | ABC | CV | ABC-123 | 4 | AR-Aneurysm | ABNEXAM | Examination for Abnormality | Abdominal region | NON-TARGET FOR STUDY TREATMENT (MONITORING) | Aneurysm |
| Aneurysm | Aneurysm |
| Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 | | 5 | ABC | CV | ABC-123 | 5 | TR-Aneurysm | LENGTH | Length |
| TARGET FOR STUDY TREATMENT | 4 | cm | 4 | 4 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 | | 6 | ABC | CV | ABC-123 | 6 | TR-Aneurysm | MAXLDIA | Maximal Luminal Diameter |
| TARGET FOR STUDY TREATMENT | 5 | cm | 5 | 5 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 | | 7 | ABC | CV | ABC-123 | 7 | AR-Aneurysm | LENGTH | Length |
| NON-TARGET FOR STUDY TREATMENT (MONITORING) | 2 | cm | 2 | 2 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 | | 8 | ABC | CV | ABC-123 | 8 | AR-Aneurysm | MAXLDIA | Maximal Luminal Diameter |
| NON-TARGET FOR STUDY TREATMENT (MONITORING) | 2.5 | cm | 2.5 | 2.5 | cm |
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| CT SCAN | 1 | BASELINE | 2020-04-27 |
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What goes into TULOC?
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 chest/thorax and everything in it. You can view the images in three angles: a) axial view (you are looking at the picture of the thorax from the direction of head to toe), b) the coronal view (you are looking at the images of the thorax as if you are standing in front of the person), c) sagittal view (you are looking at the picture of the thorax from the side). Hence TULOCs are populated with Thoracic Region and Abdominal Region for now. 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 which region you are looking at because the anatomy of both regions are so different and clearly sperpated. I think it is not wrong to populate TULOC with chest and abdomen as well, they are just not the most precise anatomical terms.
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