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© 2019 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the AJCC TNM Staging System 7th Edition (AJCC V7) as a clinical  as a clinical classification instrument. This  This version of the AJCC manual was published in 20092010. 

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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The CDISC Intellectual Property Policy can be found on the CDISC web site at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

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 of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text 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 standard.

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).

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Edge SB, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A, editorseds. AJCC cancer staging manual (7th ed)Cancer Staging Manual. 7th ed. New York, NY: Springer; 2010.

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The AJCC V7 includes a staging form that doctors use to determine the anatomic stage of cancer. Tumor size, the extent of regional lymph nodes, and the extent of distant metastases are first determined and assigned codes. These codes are then used to determine the anatomic stage. Users need to should refer to the AJCC V7 manual and applicable staging forms for more information on the TNM codes. 

1. There are three 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.
   
2. TNM staging codes are typically assigned according to staging windows (e,g., clinical, pathological, recurrent, post-therapy, autopsy). These staging windows are identified using prefixes (e.g., "c", "p", "a", "yc", "yp" or , "r".). Often the "c" prefix is assumed and not included. When prefixes are used, they are appended to the TNM staging codes (e.g., "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 classification, the type of cancer is stored in RSSCAT (e.g., For 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. 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.  

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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.

A decision was made not to include mapping strategies for all cancer types. Users will need to should refer to the AJCC V7 manual and applicable staging form for further TNM staging codes used in other cancer types.

AJCC has defined prefix designators that may be used to indicate the different points in time that when 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 of T, N, and M by pathologic means is denoted by use of a lower-case case "p" prefix (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 /and suffixes are included in the AJCC V7 Manual.  

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

• The "m" suffix indicates the presence of multiple primary tumors in a single site and is recorded in parentheses: pT(m)NM.
• The "y" prefix indicates those cases in which classification is performed during or following initial multimodality therapy. The cTNM or pTNM category is identified by a "y" prefix. The ycTNM or ypTNM categorizes the extent of tumor actually present at the time of that examination. The "y" categorization is not an estimate of tumor prior to multimodality therapy.
• "r" prefix indicates a recurrent tumor when staged after a disease-free interval, identified by the "r" prefix: rTNM.
• "a" prefix designates the stage determined at autopsy: aTNM

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