...

Revision History

© 2020 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

...

The representation of data collected for this clinical classification instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this clinical classification are this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

...

CDISC specifies how to structure the data that data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocolsto conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.

2 Copyright Status

Springer owns the copyright for the AJCC V7 instruments and has granted CDISC permission to include this supplement in the CDISC library inventory of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual  text on the clinical classification. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standardtext on this instrument.

These materials discuss and/or include one or more of the AJCC V7 instruments, which are owned exclusively by Springer. No part of the AJCC V7 instruments may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Springer and payment of any applicable fees. Copyright Springer. All rights reserved.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF (s) annotated with the CDISC SDTMIG variables with submission values (AJCC V7 Annotated CRF.pdf).

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

...

1. There are 3 components of tumor staging, frequently called TNM staging. These components are turmor tumor size (T), the extent of regional lymph nodes (N), and the extent of distant metastasis (M). Each component is classified with a combination of letters and numbers (e.g., "T0", "M1a"). For the AJCC V7, the classification results are stored in RSORRES and RSSTRESC.
   
   1. In addition to TNM staging, the absence or presence of residual tumor after treatment can be represented in RSTESTCD = AJCC105 with values stored in RSORRES and RSSTRESC (e.g., RSORRES and RSSTRESC = "RX").
2. TNM staging codes are typically assigned according to staging windows (e,g., clinical, pathological, recurrent, posttherapy, autopsy). These staging windows are identified using prefixes (e.g., c, p, a, yc, yp, r). Often the c prefix is assumed and not included. When prefixes are used, they are appended to the TNM staging codes (e.g., RSORRES = "rT1aN2M0"); the prefix r is appended to the TNM code and stored in RSORRES and RSSTRESC. See Section 4, SDTM Mapping Strategy, for further details.

3. For the AJCC V7 clinical classificationinstrument, the type of cancer is stored in RSSCAT (e.g., For lung cancer, RSSCAT = "LUNG CANCER").

4. The text descriptions and definitions associated with each TNM code are specific to each cancer type. These text descriptions of the codes are not represented in the dataset.

5. Records are created in rs.xpt for every instrument item: 

   1. For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in RSREASND (e.g., RSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND is missing.

6. Terminology:

   1. RSCAT, RSTESTCD, and RSTEST use approved CDISC Controlled Terminology.

   2. An example list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.  

...

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES and RSSTRESC) should be populated for RSSCAT = "LUNG CANCER". Special cases of TNM classifications are also described.

...

AJCC has defined prefix designators that may be used to indicate the different points in time that staging may be determined. For example, staging may be determined before any treatment (clinical stage) or after surgery (pathologic stage). As described in the AJCC V7 Cancer Staging Manual, the prefix/suffix of c, p, yc, yp, m, r, or a may be applied. For example, the classification the classification of T, N, and M by pathologic means is denoted by use of a lower-case p prefix (pTe.g., pT, pN, pM). The c prefix is not generally used, but rather assumed, when just TNM is stated. A complete description of and definitions for these prefixes/suffixes are included in the AJCC V7 Manual.  

The m suffix and y, r, and a prefixes indicate the following:

...

RSTESTCD = "AJCC105" RSTEST = "AJCC1-Residual Tumor (R)"

End of Document