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HemaGuide – A case-grounded AI agent for clinical decision support in hematological malignancies

HemaGuide – A case-grounded AI agent for clinical decision support in hematological malignancies - HemaGuide

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039888
Enrollment
700
Registered
2026-06-16
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All hematological entities that are typically discussed at the tumor boards, for example malignant lymphomas, plasmacytoma/multiple myeloma, leukemias, other malignant neoplasms of lymphoid/hematopoietic tissue, as well as polycythemia vera, myelodysplastic syndromes, and other myeloproliferative neoplasms. C81-C96

Interventions

Group 1: Therapy recommendation generated by the LLM agent HemaGuide based on the original tumor board input data. Blinded to the clinical tumor board
no clinical intervention. Group 2: Documented therapy decision of the regular hematology tumor boards, as documented at the time of the original patient care and recorded in the hospital information s

Sponsors

Universitätsklinikum Heidelberg, Klinik für Innere Medizin V: Hämatologie, Onkologie und Rheumatologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients whose hematological-oncological case was presented and discussed at least once at a hematology tumor board between 2024 and 2025 and for whom a documented tumor board therapy recommendation is available.

Exclusion criteria

Exclusion criteria: Excluded were tumor board cases in which the primary question concerned radiological image interpretation (e.g., pure restaging presentations without a resulting therapy decision), cases with incomplete or non-reconstructible documentation of the tumor board decision, cases without a documented therapy recommendation, as well as cases with incomplete clinical findings required for a reproducible therapy decision.

Design outcomes

Primary

MeasureTime frame
Proportion of cases (%) in which the recommendation generated by the LLM agent agrees with the documented tumor board decision (reference standard). For this, the LLM agent is applied to de-identified tumor board cases in routine clinical care. Agreement is assessed per case using a specifically developed Tumor Board Concordance Score (TBCS, 10 points); concordance is defined as a total score = 8/10. Assessment is performed by two independent hematologists - with a third independent rater adjudicating in cases of disagreement. The concordance rate is calculated across all included cases.

Secondary

MeasureTime frame
1. Reduction in hallucination rate across all evaluated cases. 2. Classification of discordant cases into clinically interpretable categories. 3. Stratification by guideline conformity, patient-context integration, reasoning transparency, clinical utility, and run-to-run consistency. 4. Median and p95 inference time and token count per case on standard hardware, stratified by decision mode.

Countries

Germany

Contacts

Public ContactMirco Friedrich

Universitätsklinikum Heidelberg, Klinik für Innere Medizin V: Hämatologie, Onkologie und Rheumatologie

mirco.friedrich@med.uni-heidelberg.de+496221560

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026