TU domain modeling problem statements

Problem Statements

Tumors are neoplastic lesions while an aneurysm is a non-neoplastic lesion. They all are considered as lesions, why is the modeling for the two types of lesions so different and inconsistent in TU?

TU/TR/RS were originally created for tumor identification and (tumor) disease assessment data. Non-tumor lesion modeling was later added onto TU/TR. RS was also combined with CC in either 2018 or 2019.

Arguments have been made that Tumor finding data modeling is prefaced on “already identified tumors”. TU records are created for each “identified tumor”, with the creation of a unique tumor ID (TULNKID). Since only already identified tumors are mapped to TU, this means, the locations (produced by imaging procedures) where one looked for the presence of a tumor and didn’t find it, is NOT modeled in TU.

• This is in part due to the fact that imaging location is treated as a procedure attribute and is mapped to procedure.

The results for TUTEST = Tumor Identification, are typically TUORRES = Target and Non-target. However results for this test can also be: BONE LESION, measurable/non-measurable, benign/malignant, new, etc. I think the purpose of this test is to identify the “role” of a tumor, such as tumor type, malignancy status, measurability, etc. However, TU domain definition also states that TU is used to identify the location of the tumor. There is no specific TUTEST associated with the tumor location identification process - tumor locations are treated as a known fact and are mapped to TULOC directly. It isn't clear whether TUTEST = Tumor Identification, is also intended to be used to identify the location of the tumor.

Identified tumors are assessed to be target/non-target according to published criterion (e.g. RECIST) and this is to classify tumors for subsequent disease assessments to treatment (RS).

This doesn’t work for non-tumor lesions, because:

1. There is a need to model whether or not a non-tumor lesion is identified in a region.
   1. This requires imaging location to be modeled in the TU domain.
   2. TU modeling needs to allow the creation of a “negative” record – I looked at this location but didn’t find what I suspected”.
2. Once a non-tumor lesion is identified, it may not always undergo “Assessment of disease response to therapy (i.e. RS)”, it may be further classified based on severity, anatomy or other types of classifications. In this case, this should be modeled in the CC portion of the RS/CC combined domain.

The concept map below describes the modeling discripencies between tumor and non-tumor lesions. Note the dotted lines and boxes indicate a step that didn't happen and data not modeled.

Agreed Approaches

1. Imaging location should be treated as the TEST Location when identifying the location of a suspected object.

Questions

• If all I need to do is to identify an object, it’s location, and then evaluate its severity, no disease response to treatment data, in other words I have TU and CC data, but no TR, can I use TU?