Pancreatic Cancer Primary Tumor Characteristics

Illustrates Domains

TU
TR

Illustrates Variables

TUTEST
TUTESTCD
TULOCDTL
TRTEST
TRTESTCD
TRREASND
TRMETHOD
TREVAL

Content

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.

tu.xpt

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.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	VISITNUM	VISIT	VISITDY	TUDTC	TUDY	TULOCDTL
1	PACA110	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
3	PACA110	TU	009	1	PT1	TUMIDENT	Tumor Identification	PRIMARY	PRIMARY	PANCREAS, TAIL	1	SCREENING	-1	2012-06-18	-75

TU NSV Metadata

Variable	Label	Type	Role	Origin
TULOCDTL	Location Detail	text	Non-standard Variable Qualifier	CRF

The TR domain was used to represent assessments on the primary tumor.

tr.xpt

Row 1:	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.
Rows 3-6:	Show the diameters of the primary tumors at diagnosis and upon resection.

tr.xpt

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRSTAT	TRREASND	TRMETHOD	TREVAL	VISITNUM	VISIT	VISITDY	TRDTC	TRDY
1	PACA110	TR	007	1	PT1	LDIAM	Longest Diameter						NOT DONE	TUMOR NOT EVALUABLE	CT-SCAN	RADIOLOGIST	1	SCREENING	-1	2014-01-16	-100
2	PACA110	TR	007	2	PT1	LDIAM	Longest Diameter	13	mm	13	13	mm			GROSS EXAMINATION	PATHOLOGIST	1	SCREENING	-1	2014-03-16	-17
3	PACA110	TR	008	1	PT1	LDIAM	Longest Diameter	30	mm	30	30	mm			CT-SCAN	RADIOLOGIST	1	SCREENING	-1	2013-11-16	-60
4	PACA110	TR	008	2	PT1	LDIAM	Longest Diameter	20	mm	20	20	mm			GROSS EXAMINATION	PATHOLOGIST	1	SCREENING	-1	2013-12-16	-21
5	PACA110	TR	009	1	PT1	LDIAM	Longest Diameter	21	mm	21	21	mm			CT-SCAN	RADIOLOGIST	1	SCREENING	-1	2012-06-18	-70
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.

relrec.xpt

relrec.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
1	PACA110	TU		TULNKID		ONE	PT1
2	PACA110	TR		TRLNKID		MANY	PT1