MII IG Kerndatensatz-Modul Onkologie
2027.0.0-ballot.1 - Germany

This page is part of the MII IG Kerndatensatz-Modul Onkologie (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Tumor Markers: Curated LOINC Codes

Context and Purpose

According to the ENCR recommendation Basis of Diagnosis (October 2022), a cancer diagnosis can also be made without histology via specific tumour markers in combination with clinical examination (Basis of Diagnosis 4 — corresponding to oBDS diagnostic confirmation 4 "specific tumour markers"). Table 4 of the recommendation names the serum/plasma and urine markers accepted for this purpose together with the associated entities.

This page documents the curated LOINC code list for that table. It serves as a reference for implementers who wish to link tumour marker laboratory values (via the KDS module Laboratory) with oncological diagnoses. A binding ValueSet is deliberately not yet part of the package — it will follow once the clinical review of the core list is complete and the binding location has been decided (a dedicated laboratory profile vs. a reference to the KDS Laboratory module).

Curation Principle

For each marker, the method-independent LOINC code of the usual matrix is chosen (serum/plasma; for catecholamine metabolites, 24-hour urine). This keeps the list stable against variations in method, unit and device; more specific codes can be added as needed via the LOINC-SNOMED ontology (see below).

Each code was verified individually against LOINC (MII terminology server and tx.fhir.org). This is not optional: during curation, five obvious candidates turned out to be false matches — for example 3126-0 would have been vasopressin instead of VIP (3125-2), and 15061-5 erythropoietin instead of somatostatin (2961-1).

Core List: General LOINC Codes

Marker LOINC Display Typical entity
CEA 2039-6 Carcinoembryonic Ag [Mass/volume] in Serum or Plasma Colorectal carcinoma
AFP 1834-1 Alpha-1-Fetoprotein [Mass/volume] in Serum or Plasma HCC, germ cell tumours
CA 19-9 24108-3 Cancer Ag 19-9 [Units/volume] in Serum or Plasma Pancreatic/bile duct carcinoma
CA-125 10334-1 Cancer Ag 125 [Units/volume] in Serum or Plasma Ovarian carcinoma
PSA 2857-1 Prostate specific Ag [Mass/volume] in Serum or Plasma Prostate carcinoma
hCG 19080-1 Choriogonadotropin [Units/volume] in Serum or Plasma Choriocarcinoma, germ cell tumours
β-hCG 21198-7 Choriogonadotropin.beta subunit [Units/volume] in Serum or Plasma Choriocarcinoma, germ cell tumours
Chromogranin A 9811-1 Chromogranin A [Mass/volume] in Serum or Plasma NET, phaeochromocytoma
Insulin 20448-7 Insulin [Units/volume] in Serum or Plasma Insulinoma
Glucagon 2338-2 Glucagon [Mass/volume] in Serum or Plasma Glucagonoma
Gastrin 2333-3 Gastrin [Mass/volume] in Serum or Plasma Gastrinoma
VIP 3125-2 Vasoactive intestinal peptide [Mass/volume] in Serum or Plasma VIPoma
Somatostatin 2961-1 Somatostatin [Mass/volume] in Plasma Somatostatinoma
Serotonin 18253-5 Serotonin [Mass/time] in 24 hour Urine NET (serotonin-producing)
ACTH 2141-0 Corticotropin [Mass/volume] in Plasma ACTH-producing tumours
Calcitonin 1992-7 Calcitonin [Mass/volume] in Serum or Plasma Medullary thyroid carcinoma
HVA 2436-4 et al. homovanillate — 24-hour urine, concentration, creatinine ratio (also random urine) Neuroblastoma
VMA 3122-9 et al. vanillylmandelate — 24-hour urine, concentration, creatinine ratio (also random urine) Neuroblastoma
Catecholamines 27055-3, 2058-6, 2056-0 free/total in 24-hour urine, catecholamines in plasma Phaeochromocytoma
Metanephrines 43108-0, 57462-4, 2609-6 metanephrine/normetanephrine panel in serum or plasma (diagnostic standard), metanephrines in 24-hour urine Phaeochromocytoma
Prolactin 2842-3 Prolactin [Mass/volume] in Serum or Plasma Prolactinoma
GH/somatotropin 2963-7 Somatotropin [Mass/volume] in Serum or Plasma Pituitary tumours
FSH 15067-2 Follitropin [Units/volume] in Serum or Plasma Pituitary tumours
LH 10501-5 Lutropin [Units/volume] in Serum or Plasma Pituitary tumours
TSH 3016-3 Thyrotropin [Units/volume] in Serum or Plasma Pituitary tumours
M protein 33358-3 Protein.monoclonal [Mass/volume] in Serum or Plasma by Electrophoresis Multiple myeloma
IgG 2465-3 IgG [Mass/volume] in Serum or Plasma Multiple myeloma
IgA 2458-8 IgA [Mass/volume] in Serum or Plasma Multiple myeloma
IgM 2472-9 IgM [Mass/volume] in Serum or Plasma Waldenström's disease, myeloma

Note on specimen material (matrix). Which marker and which specimen a laboratory uses depends on the clinical question and the assay — where this is ambiguous the list therefore carries all common variants rather than picking one. For serotonin-producing NET these are:

Marker Material LOINC
5-HIAA (clinical standard, metabolite) 24-hour urine 1695-6 (mass/time), 31203-3 (concentration)
5-HIAA random urine 1694-9
5-HIAA/creatinine ratio 24-hour urine 44288-9
Serotonin 24-hour urine 18253-5
Serotonin serum / plasma / whole blood 27057-9 / 2940-5 / 2939-7

5-HIAA is more stable than serotonin itself, which fluctuates strongly (platelet content, food intake, time of day). As the value set is bound extensibly, further matrices are permitted anyway.

ENCR Table 4: marker → permissible morphology

Table 4 of the ENCR recommendation Basis of Diagnosis lists the entities that may be recorded on the basis of elevated tumour markers (together with clinical investigations) when pathological confirmation is unavailable — each with the morphology to be assigned in that case. This is the clinical basis of oBDS basis-of-diagnosis code 4 "specific tumour markers". All ICD-O codes are verified against the MII terminology server (ICD-O-3 second revision 2019).

Entity Tumour marker ICD-O morphology
Kolorektales Karzinom CEA 8000/3 Maligne Neoplasie
Hepatozelluläres Karzinom AFP 8170/3 Hepatozelluläres Karzinom o.n.A.
Pankreas-, Gallenblasen-/Gallenwegskarzinom CA 19-9 8000/3 Maligne Neoplasie
Ovarialkarzinom CA-125 8000/3 Maligne Neoplasie
Prostatakarzinom PSA 8000/3 Maligne Neoplasie
Chorionkarzinom der Plazenta hCG 9100/3 Chorionkarzinom o.n.A.
Keimzelltumor hCG oder AFP (± hCG) 9064/3 Germinom bzw. 9065/3 Nichtseminomatöser Keimzelltumor
Neuroendokriner Tumor Chromogranin A 8240/3 Neuroendokriner Tumor o.n.A.
Funktionelle neuroendokrine Tumoren Insulin, Glukagon, Gastrin, VIP, Somatostatin, Serotonin, ACTH 8151/3–8158/3 (z. B. 8151/3 Insulinom o.n.A., 8158/3 ACTH-produzierender Tumor)
Medulläres Schilddrüsenkarzinom Calcitonin 8345/3 Medulläres Schilddrüsenkarzinom
Neuroblastom Katecholaminabbauprodukte (HVA, VMA) 9500/3 Neuroblastom o.n.A.
Prolaktinom Prolaktin 8271/0 Laktotrophes Adenom
Andere funktionelle Hypophysentumoren STH, FSH, LH, ACTH, TSH 8272/0 Hypophysenadenom o.n.A.
Phäochromozytom Katecholamine, Chromogranin A 8700/3 Phäochromozytom o.n.A.
Multiples Myelom M-Protein (IgG, IgM, IgA) > 30 g/L 9732/3 Plasmazellmyelom
Morbus Waldenström IgM 9761/3 Waldenström-Makroglobulinämie

Completeness: every marker named in Table 4 carries a LOINC code in the core list above; the core list goes further (e.g. β-hCG listed separately).

Source: Van Eycken L. et al., 2022 revised European recommendations for the coding of the basis of diagnosis of cancer cases in population-based cancer registries, Front Oncol 2023;13:1250549 — doi:10.3389/fonc.2023.1250549.

Extension via the LOINC-SNOMED Ontology

The LOINC-SNOMED ontology (LOINC concepts as SNOMED CT observables in a dedicated extension module) makes it possible, for each marker, to navigate by subsumption from the general "Measurement of …" observable to all more specific variants (method, unit, specimen material) — and thus to form implicit, hierarchically defined ValueSets instead of maintaining individual codes.

For 23 of the 28 markers the observable anchor has been verified (e.g. CEA → Measurement of carcinoembryonic antigen in serum or plasma 723431010000109 with mass/substance/arbitrary concentration children). For the remaining five (gastrin, calcitonin, M protein, IgA, IgM) no grouper concept exists — see the addendum below.

The complete curation report with all anchors and child concepts is located in the repository at input/examples-source/biomarker/biomarker-snomed-report.md.

Addendum 2026-08-28. For seven of the twelve previously open markers the anchor has now been determined and verified (Snowstorm branch MAIN/SNOMEDCT-LOINC, ECL over <<363787002 |Observable entity|):

Marker LOINC SNOMED anchor Designation Children
beta-hCG 21198-7 727021010000108 Measurement of human chorionic gonadotropin beta subunit in serum or plasma 4
HVA 2436-4 732491010000101 Measurement of homovanillic acid in urine 10
VMA 3122-9 731001010000107 Measurement of vanillylmandelic acid in urine 11
ACTH 2141-0 721541010000101 Measurement of adrenocorticotropic hormone in plasma 200
FSH 15067-2 726901010000101 Measurement of pituitary follicle stimulating hormone in serum or plasma 100
LH 10501-5 724461010000100 Measurement of pituitary luteinizing hormone in serum or plasma 96
TSH 3016-3 727041010000103 Measurement of thyrotrophin in serum or plasma 79

For gastrin, calcitonin, M-protein, IgA and IgM the LOINC-SNOMED ontology holds no "Measurement of …" grouper for the serum/plasma determination in question — only the concrete measurands (mass/substance concentration …) are modelled there. For those markers navigation via the general LOINC code remains the only option; a grouper would have to be requested from SNOMED International.

Methodological note: the LOINC-SNOMED concepts live in a separate Snowstorm branch (MAIN/SNOMEDCT-LOINC) and are not discoverable through the standard FHIR expansion of the International Edition. A naive text search is also reliably misleading — it returns corticotropin releasing factor for ACTH and the thyrotropin receptor antibody for TSH. The anchors listed here were cross-checked individually via FSN and child concepts.

Open Points

  • Clinical review of the core list (codes and entity assignments).
  • LOINC-SNOMED anchors: 23 of 28 verified; for 5 markers no grouper exists (a request to SNOMED International would be required).
  • Decision on the binding location decided (2026-08-28): laboratory values are carried by the CDS module Laboratory Report. This module provides the profile MII_PR_Onko_Tumormarker — a derivation of MII_PR_Labor_Laboruntersuchung that binds Observation.code extensibly to the union list mii-vs-onko-tumormarker-loinc and adds the link to the oncological diagnosis (focus).
  • Serotonin matrix decided (2026-09-01): all common variants including 5-HIAA are listed; the choice depends on laboratory and specimen (see the note above).