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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.

CV endpoint TAUG

The example in the CV-end point TAUG use Target vs Non-target to mean: target for PVI or PCI treatment. There is NO criteria that defines what target means, i.e. size of the lesion, etc.

tu.xpt

tu.xpt

Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKID

TUTEST

TULOC

TUORRES

TUSTRESC

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC


TUTLGFFL
1

TUDY01

TU409121Lesion 1

Lesion Role Identification

POPLITEAL ARTERYNON-TARGETNON-TARGETCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07

2

TUDY01

TU409122Graft Lesion 1Lesion Role IdentificationLEFT FEMORO-POPLITEAL ARTERYTARGETTARGETCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
Y

Dataset Debug Message

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

TU NSV Metadata

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