Data Element
Staging System
Description

A cancer staging system is used to describe the extent of cancer in the body. There are many staging systems. Some, such as the TNM staging system, are used for many types of somatic cancer. Others are specific to a particular type of cancer (Source: NCI). Examples of non-TNM staging systems include the Cotswolds Modifications of the Ann Arbor Staging Classification, Revised International Staging System (R-ISS), and Rai and Binet staging systems for chronic lymphocytic leukemia.
Submitted By: May Terry / MITRE Corporation
Data Element Information
Rationale for Separate Consideration USCDI has a Cancer Care class data element called Staging System (AJCC TNM), however that is limited to only one staging system. Hematologic and lymphoma cancers like leukemia or multiple myeloma do not use TNM staging because anatomic staging does not apply. Rather, they have specialized cancer staging systems that are based on prognostic factors often based on chemistry and hematologic measures.

The overall stage for both TNM and non-TNM staging systems might have similar values, but the critieria that determined the stage is completely different. This could result in a misinterpretation in a cancer care pathway for treatment and monitoring. As a result, when a cancer is staged, the system or classification used in the staging must be specified.
Use Case Description(s)
Use Case Description Several use cases are actively implementing this data element:

The CodeX Clinical Trial Matching Use Case aims to automate the existing trial matching process and complete the eligibility screening in one step to increase enrollment and diversity of patients in clinical trials. There are 11 key partners, including industry, advocacy organizations, and research, involved in the use case. Additionally, this use case is in process of rolling out into prospective phase at one health site, UTSW.

The CodeX Registry Reporting Use Case aims to share cancer registry data in a standardized, low burden method to better track patient outcomes. There are 7 key partners, including government, industry, and research, involved in the use case. Note that CDC and other stakeholder involvement in the use case led to mCODE’s utilization for cancer data elements in the [IG].

The CodeX Prior Authroization Use Case aims to improve access to care for cancer patients with a focus to leverage the implementation guides developed by the HL7 Da Vinci Accelerator as well as CodeX mCODE. There are there are approximately 11-12 organizations involved in the PA use case. Those organizations are associations, EHR, providers, health plans, technology vendors who support payers and providers, and a utilization management organization. HHS – OBRHI and ONC have expressed interest in the use case.

The CodeX Quality Measures Use Case aims to highlight new quality measures that could be developed – and new insights that could be made – if mCODE and other FHIR IGs (such as QI Core) were implemented and leveraged by an ecosystem of willing health organizations. There are 4 key partners including industry, research, and professional organization involved in the use case.
Estimate the breadth of applicability of the use case(s) for this data element The staging systems could apply to multiple domains. There is cancer staging as noted in the definition above. However there are also different staging systems that could apply for assessing heart failure stages.
Use Case Description There is work underway to adapt existing standards like the minimum Common Oncology Data Elements (mCODE) to support cancers more common in pediatric and adolescent/young adult (AYA) populations, like non-solid tumors, require additional staging classifications.

The CC-DIRECT initiative (link: https://www.whitehouse.gov/briefing-room/statements-releases/2023/02/02/fact-sheet-on-one-year-anniversary-of-reignited-cancer-moonshot-biden-harris-administration-announces-new-actions-to-end-cancer-as-we-know-it/) has established relevant elements in mCODE STU3.

From the use case perspective CC-DIRECT is focused on transition of care to a secondary/tertiary referral center as well as trial matching.
Estimate the breadth of applicability of the use case(s) for this data element As of 2016, there were approximately 2,560 pediatric oncologists in the United States (https://www.statista.com/statistics/373987/physicians-in-the-us-by-oncology-specialty/).
Link to use case project page https://www.whitehouse.gov/briefing-room/statements-releases/2023/02/02/fact-sheet-on-one-year-anniversary-of-reignited-cancer-moonshot-biden-harris-administration-announces-new-actions-to-end-cancer-as-we-know-it
ONC Priority
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) SNOMED CT specifies codes for describing different cancer staging systems.
mCODE further specifies a value set of SNOMED CT codes for cancer staging systems (http://hl7.org/fhir/us/mcode/ValueSet-mcode-cancer-staging-system-vs.html).

http://hl7.org/fhir/us/mcode/ValueSet-mcode-cancer-staging-system-vs.html
Additional Specifications • The HL7 minimum Common Oncology Data Elements (mCODE) FHIR IG Cancer Stage Group FHIR profile specifies an element to identify the staging system.

• The HL7 Clinical Document Architecture (CDA) Cancer Registry Reporting IG contains template 2.16.840.1.113883.10.13.32:2015-04-02 to specify No Known TNM Pathologic Stage Observation, used for specifying cancers with no TNM staging system such as leukemias.

• The NAACCR Site Specific Data Item (SSDI) 2023 manual identifies non-TNM staging systems like Revised International Staging System (R-ISS) for staging plasma cell myeloma (source: NAACCR). R-ISS relies on completely different prognostic factors for evaluating the stage.
Current Use (Level 0) Captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration
Extent of exchange (Level 0) Limited environments, such as connectathons or pilots
Supporting Artifacts EHRs with specialty oncology modules contain elements that specify the staging system used in evaluating the extent of disease.

These include fields for capturing non-TNM staging systems such as the Cotswolds Modifications of the Ann Arbor Staging Classification, Revised International Staging System (R-ISS), and Rai and Binet staging systems for chronic lymphocytic leukemia.
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) There are no restrictions on the standardization of this data element. All models and codes are available for public use.
Restrictions on Use (e.g. licensing, user fees) There are no SNOMED-CT restrictions on the use of this data element for United States-based entities.
Privacy and Security Concerns There are no privacy and/or security concerns on the exchange of this element.
Estimate of Overall Burden This element has been relatively easy to capture in EHRs which cancer modules that have staging calculators. It is captured as an electronic form field which specifies the staging system or classification.
Some terminology mapping may be needed from a system’s local code to SNOMED-CT, but this is a relatively short list and does not require much implementation effort. The mCODE FHIR IG also provides a value set of staging systems that will ease the mapping process.
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element represents data in a specialized use case of cancer care.

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