Revision History

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

1 Introduction

This document describes the CDISC implementation of the American Joint Committee on Cancer (AJCC) TNM Staging System 7th Edition (AJCC V7) as a clinical classification instrument. This version of the AJCC manual was published in 2010. 

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

The representation of data collected for this clinical classification 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 meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

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 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. 

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.

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.

CDISC acknowledges Springer for the approval to include the AJCC V7 in the CDISC data standards.

Reference for the AJCC TNM Staging System 7th Edition (AJCC V7):

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

3 The RS Domain Model

3.1 Assumptions for RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the AJCC V7 are listed below.

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 should refer to the AJCC V7 manual and applicable staging forms for more information on the TNM codes. 

1. There are 3 components of tumor staging, frequently called TNM staging. These components are 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", "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 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.  

3.2 Example for the AJCC V7 RS Domain Model

The AJCC V7 example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at visit 1 for an AJCC V7 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES and RSSTRESC. 

The table represents the items from the AJCC V7 form for a subject with lung cancer.

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.

This supplement does not include mapping strategies for all cancer types. Users should refer to the AJCC V7 and applicable staging forms for TNM codes used in other cancer types.

AJCC has defined prefix designators that may be used to indicate the different points in time 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, 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 the lower-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.  

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 present at the time of the examination. The "y" categorization is not an estimate of tumor prior to multimodality therapy.
• The "r" prefix indicates a recurrent tumor when staged after a disease-free interval: rTNM.
• The "a" prefix designates the stage determined at autopsy: aTNM

The following is an example of the mapping strategy for the AJCC V7 as applied to lung cancer (RSSCAT = "LUNG CANCER"). The "m" suffix and "y", "r", and "a" prefixes could be attached to any of the results below.

RSTESTCD = "AJCC101" RSTEST = "AJCC1-Primary Tumor (T)"

RSTESTCD = "AJCC102" RSTEST = "AJCC1-Regional Lymph Nodes (N)"

RSTESTCD = "AJCC103" RSTEST = "AJCC1-Distant Metastasis (M)"

RSTESTCD = "AJCC104" RSTEST = "AJCC1-Anatomic Stage"

End of Document