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Title

AJCC TNM Staging System 7th Edition (AJCC V7)

CDISC Reference

Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short Name

AJCC V7

QRS Permission StatusApproved
TeamLuCa Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date20192020-0805-1219
NotesThis supplement is intended to be used with other CDISC User Guides user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


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Revision History

Date

Version

20192020-0805-12191.0 Draft

© 2019 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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 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 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-therapyposttherapy, 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 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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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 of T, N, and M by pathologic means is denoted by use of a 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/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.
  • "The r" prefix indicates a recurrent tumor when staged after a disease-free interval, identified by the "r" prefix: rTNM.
  • "T a" prefix  prefix designates the stage determined at autopsy: aTNM

Following is an example of the mapping strategy for 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.

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