In this example, the study enrolled subjects who had a primary tumor located in the pancreas. Subjects were enrolled after the completion of neoadjuvant therapy and any surgery performed to resect the primary tumor after completing the neoadjuvant therapy. The size of the primary tumor at initial diagnosis (determined by a scan) and the size of the tumor upon resection (determined by a pathologist) were collected. In this document, the residual tumor status after surgery was assigned according to the AJCC staging system and represented in the RS domain (see Section 3.4, Staging History).
The primary tumor was represented in the Tumor/Lesion Identification (TU) domain and assigned a TULNKID; the assessments on the primary tumor were represented in the Tumor/Lesion Results (TR) domain. Because information on the primary tumor was of interest, TUORRES was populated with "PRIMARY". TUDTC represents the date of the scan/image/physical exam associated with this evaluation. A sponsor may elect to use only TUDTC and TUDY, or to include the SDTM concept of disease milestones to provide information about the timing of these assessments. More information about disease milestones can be found in the SDTMIG.
|Rows 1, 3:|
TUTEST = Tumor Identification was used to identify the lesion of interest in this study (e.g., the primary tumor). These records are associated with the assessment results in the TR domain using TULNKID.
|Row 2:||The primary tumor was located in the pancreas. Location details are represented in the NSV TULOCDTL.|
|TU||007||1||PT1||TUMIDENT||Tumor Identification||PRIMARY||PRIMARY||PANCREAS, BODY||1||SCREENING||-1||2014-01-16||-100|
|2||PACA110||TU||008||1||PT1||TUMIDENT||Tumor Identification||PRIMARY||PRIMARY||PANCREAS||1||SCREENING||-1||2013-11-16||-60||OVERLAPPING BODY AND TAIL|
TU NSV Metadata
|TULOCDTL||Location Detail||text||Non-standard Variable Qualifier||CRF|
The TR domain was used to represent assessments on the primary tumor.
Shows determination of the longest diameter of the primary tumor by CT scan at diagnosis. In this case, the tumor could not be evaluated.
|Row 2:||Shows the longest diameter of the primary tumor upon resection. The size was determined from the resected primary tumor by the pathologist.|
Show the diameters of the primary tumors at diagnosis and upon resection.
TUMOR NOT EVALUABLE
|2||PACA110||TR||007||2||PT1||LDIAM||Longest Diameter||13||mm||13||13||mm||GROSS EXAMINATION||PATHOLOGIST||1||SCREENING||-1||2014-03-16||-17|
|4||PACA110||TR||008||2||PT1||LDIAM||Longest Diameter||20||mm||20||20||mm||GROSS EXAMINATION||PATHOLOGIST||1||SCREENING||-1||2013-12-16||-21|
|6||PACA110||TR||009||2||PT1||LDIAM||Longest Diameter||4||mm||4||4||mm||GROSS EXAMINATION||PATHOLOGIST||1||SCREENING||-1||2012-10-15||-30|
The relationship between the TU and TR datasets is represented in RELREC.