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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:

Include Page
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention

Example 1: Observed abnormality that's also a lesion, but "non-target" for study intervention

...

, it is not treated and continuously monitored.

Dataset wrap
titlecv.xpt
NamePR


Dataset2


Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

 11  ABCPR  ABC-1231CT SCANCHESTBASELINE2  ABCPR  ABC-1232CT SCANABDOMENBASELINE



The chest CT revealed a large aneurysm in the thoracic aorta which is "A small aneurysm is revealed by the abdomen CT scan. This aneurysm is small and is considered as "non-target" for study intervention. Note the use of the NSV TUFLAG to show that this abnormality is also  even though it can be considered as a lesion for study intervention, tracking and/or disease response to treatment assessment., it should still be represented in CV. This includes its initial identification as well as all measurements of this aneurysm. 

Dataset wrap
titlecv.xpt
Namecv


Dataset2
hi3TURESLOC
hi2styleyellow
hi3styleBOLD


ROW

STUDYID

DOMAIN

USUBJID

CVSEQCVLNKIDCVGRPIDCVTESTCD

CVTEST

CVLOC

CVORRES

CVORRESUCVSTRESCCVSTRESNCVSTRESUCVRESLOCCVRLODTL

CVMETHOD

VISITNUM

VISIT

CVDTC


CVTNTSINCVTUFLAGTUFLAG
1ABCCVABC-1231TRARABNINDAbnormality IndicatorThoracic Abdominal regionY
YY


CT SCAN

1BASELINE2020-04-27


2ABCCVABC-1232TRAR-AneurysmABNEXAMExamination for AbnormalityThoracic Abdominal regionAneurysm
AneurysmAneurysmThoracic Aorta
Infrarenal aortaproximal to the iliac bifurcationAortic Arch to Descending aorta

CT SCAN

1BASELINE2020-04-27
Non-target for study intervention
3ABCCVABC-1233TRAR-DissectionAneurysmABNEXAMLENGTHExamination for AbnormalityThoracic regionArterial DissectionArterial DissectionArterial DissectionLength
2cm22cmDescending aorta

CT SCAN

1BASELINE2020-04-27


4ABCCVABC-1234TRAR-AneurysmTARGSINTTarget for Study InterventionTargetTargetTarget

CT SCAN

1BASELINE2020-04-27Y5ABCCVABC-1235TR-DissectionTARGSINTTarget for Study InterventionTargetTargetTargetMAXLDIAMaximal Luminal Diameter
2.5cm2.52.5cm

CT SCAN

1BASELINE2020-04-27Y




Nsvmeta
DomainCV


VariableLabelTypeRoleOrigin
CVTNTSINTarget/non-target for study interventiontextNon-Standard Record QualifierCRF
CVTUFLAGFlag for TU, TR or RS DatatextNon-Standard Record QualifierCRF

Shows the TU representation of the target lesions:

...

titlecv.xpt
NameTU

...

Row

...

STUDYID

...

DOMAIN

...

USUBJID

...

TUTEST

...

TULOC

...

TUORRES

...

TUMETHOD

...

VISITNUM

...

VISIT

...

TUDTC




...

CT SCAN

...

CT SCAN

...

Shows the diameter measurements of the target lesion in TR:

...

titlecv.xpt
NameTR

...

Row

...

STUDYID

...

DOMAIN

...

USUBJID

...

TRTEST

...

TRORRES

...

TRSTRESC

...

TRSTRESU

...

VISITNUM

...

VISIT

...

TUDTC

...

Example 2: Observed abnormality that's also a lesion

...

and "

...

target" for study intervention

...

The subject had a chest CT scan.

Dataset wrap
titlecv.xpt
NamePR


Dataset2


Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

1 1  ABCPR  ABC-1231CT SCANABDOMENCHESTBASELINE




A small aneurysm is revealed by the abdomen CT scan. This aneurysm is small and is considered as "non-The chest CT revealed a large aneurysm in the thoracic aorta which is "target" for study intervention even though it can be . Note the use of the NSVs TNTSIN and TUFLAG to show that this abnormality is also considered as a target lesion , it should still be represented in CV. This includes its initial identification as well as all measurements of this aneurysmfor study intervention, tracking and/or disease response to treatment assessment. When the TUFLAG is marked with Y, measurements of the lesion should be represented in TU, TR and/or RS.

AR-Aneurysm
Dataset wrap
titlecv.xpt
Namecv


proximal to the iliac bifurcation
Dataset2
hi3TURESLOC
hi2styleyellow
hi3styleBOLD


ROW

STUDYID

DOMAIN

USUBJID

CVSEQ

CVGRPID
CVLNKIDCVTESTCD

CVTEST

CVLOC

CVORRES

CVORRESU

CVSTRESCCVSTRESN
CVSTRESU
CVRESLOCCVRLODTL

CVMETHOD

VISITNUM

VISIT

CVDTC

TUFLAG

CVTNTSINCVTUFLAG
1ABCCVABC-1231
AR
TRABNINDAbnormality Indicator
Abdominal
Thoracic regionYYY

CT SCAN

1BASELINE2020-04-27


2ABCCVABC-1232
AR
TR-AneurysmABNEXAMExamination for Abnormality
Abdominal
Thoracic regionAneurysmAneurysmAneurysm
Infrarenal aorta
Thoracic AortaAortic Arch to Descending aorta

CT SCAN

1BASELINE2020-04-27
3ABCCVABC-1235non-target for study interventionnon-target for study interventionnon-target for study intervention1BASELINE2020-04-274

Target
for Study Intervention
Y
3
ABCCVABC-123
3
4
AR-Aneurysm
TR
LENGTH
ABNIND
Length
Abnormality Indicator
2
Thoracic region
cm
Y
2
Y
2cm
Y

CT SCAN

1
3
BASELINE
VISIT 22020-
04
05-27
5



4ABCCVABC-123
4
5
AR
TR-AneurysmABNEXAM
MAXLDIAMaximal Luminal Diameter2.5cm2.52.5
Examination for AbnormalityThoracic regionAneurysm decreased in sizeAneurysm decreased in size

Aneurysm decreased in size

Thoracic AortaAortic Arch to Descending aorta
cm

CT SCAN

1
3
BASELINE
VISIT 22020-
04
05-27
TargetY



Nsvmeta
DomainCV


VariableLabelTypeRoleOrigin
CVTNTSINTarget/non-target for study interventiontextNon-Standard Record QualifierCRF
CVTUFLAGFlag for TU, TR and/or RS DatatextNon-Standard Record QualifierCRF

The dissected descending aorta (LNKID =Dissection 1) is classified based on the Stanford Aortic Dissection System as type B.



Shows the TU representation of the target lesions:

Dataset wrap
titlecv.xpt
NameTU


Dataset2


Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKIDTUTESTCD

TUTEST

TULOC

TULOCDTL

TUORRES

TUSTRESC

TUMETHOD

VISITNUM

VISIT

TUDTC

1ABCTUABC-1231TR-Aneurysm
Lesion (Role) IdentificationThoracic AortaAortic Arch to Descending aortaTargetTarget

CT SCAN

1BASELINE2020-04-27



Show the diameter measurements of the target lesion in TR at two visits:Note: This test was originally created as a CVTEST, based on SDTMIG 3.4, this is now considered as a grading scale and therefore should now be represented as CC/RS.

Dataset wrap
titlecv.xpt
NameRSTR


2020-04
Dataset2


Row

STUDYID

DOMAIN

USUBJID

TRSEQTRLNKID
RSSEQ
TRTESTCD
RSLNKID

TRTEST

RSTESTCD

TRORRES

RSTEST
TRORRESU
RSCAT

TRSTRESC

RSORRES
TRSTRESN
RSSTRESC

TRSTRESU

VISITNUM

VISIT

CVDTC

TUDTC

1ABC
RS(CC)
TUABC-1231TR
-Dissection
-AneurysmLENGTHLength4cm44cmcmBASELINE2020-04-27
2ABCTUABC-1232TR-AneurysmMAXLDIAMaximal Luminal Diameter5cm55cmcmBASELINE2020-04-27
3ABCTUABC-1233TR-AneurysmLENGTHLength2cm22cmcmVISIT 22020-05-27
4ABCTUABC-1234TR-AneurysmMAXLDIAMaximal Luminal Diameter3cm33cmcmVISIT 22020-05
STAN0101STAN01-Stanford Aortic Dissection Classification TypeSTANFORD AOD CLASSIFICATIONSTANFORD BSTANFORD B1BASELINE
-27







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.

...