Tumor/Lesion Identification & Results

The CDASHIG TU domain represents data that uniquely identifies tumors and lesions (i.e., malignant tumors, culprit lesions, other sites of disease such as lymph nodes). Commonly, tumors/lesions are identified by an investigator and/or independent assessor and classified according to disease assessment criteria. For example, for an oncology study using RECIST evaluation criteria, this equates to the identification of target, non-target, or new tumors. When designing CRFs, it is common that a single CRF is designed to collect both the tumor/lesion identification information and the results of any assessments on these identified tumors/lesions.

The CDASHIG TR domain represents measurements and/or assessments of the tumors and lesions identified in the Tumor/Lesion Identification (TU) domain. When the TR domain is used, there must be a corresponding TU domain present. This multiple-domain approach was developed largely to reduce the need to collect tumor identification information at each assessment (e.g., anatomical location). A unique tumor/lesion identification number (populated in TULNKID/TRLNKID) is used to link the tumor/lesion identification (TU) with the measurement/assessments (TR). When designing CRFs, it is common that a single CRF collects both the identification information and the results of any assessments on identified tumors/lesions.

This example is for a Breast Cancer - RECIST 1.1 - Target Lesions.

The user will need to update the questions, as appropriate.

"Form TU/TR - Tumor Identification/Results [CDASH_2-1_FO_36]" Form Preview
Form TU/TR - Tumor Identification/Results
TU/TR - Tumor Identification/Results (RECIST 1.1 - Target Lesions)
Were any tumors identified? No  Yes  
What was the [Tumor/Lesion] (link) identifier?
What was the anatomical location of the [tumor/lesion] identified?
What was the laterality of the anatomical location? Left  Right  Bilateral  
What was the directionality of the anatomical location?
What [were/are] additional details on the exact location of the tumor so that it can be distinguished from other tumors in the same anatomical location?
What was the method used to [evaluate/identify] the tumor/lesion?
What was the date of the [examination/procedure] used for [tumor/lesion] identification?
 01 Jan 2000
Who provided the information?; or Who was the evaluator? Independent Assessor  Investigator  
What was the identifier of the evaluator? Radiologist 1  Radiologist 2  Radiologist 3  
Longest Diameter
Longest Diameter Unit  mm
Indicate if the tumor evaluation was not done.
What was the reason that the [tumor/lesion] was not [evaluated/assessed]?
* Mandatory field