NCT07739121

Brief Summary

BEACON (Benchmarking AI for Clinical Oncology decisioNmaking) is a prospective, multicentre, comparative, blinded, non-interventional benchmark evaluating the treatment recommendations of five frontier large language models (LLMs) against the recommendations of multidisciplinary tumour boards (RCP) in oncology treatment planning. One hundred standardised synthetic cases (20 per localisation, across breast, lung, urological, digestive and gynaecological cancers) are submitted as identical structured input to two independent tumour boards per localisation and to five frontier LLMs. Each recommendation - human or model - is decomposed into five predefined decision domains (intent, surgery, radiotherapy, systemic therapy, work-up and biomarkers) and scored 0/1/2 for concordance against a two-tier reference: the consensus of the two tumour boards, complemented by an a priori locked guideline matrix (ESMO, NCCN). The primary endpoint is domain-level concordance between LLM and RCP consensus, expressed as a linearly weighted Cohen's kappa. A co-primary safety endpoint captures the proportion of recommendations carrying serious harm potential, because concordance alone can conceal dangerous errors. Because expert boards may disagree with one another on identical cases, model performance is always interpreted against the human consensus. BEACON is designed as reusable, openly licensed, pre-registered infrastructure: all synthetic cases, evaluation rubrics, the locked guideline matrix, scoring algorithms and verbatim prompts are released for full reproducibility.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
May 2026Oct 2026

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Large Language ModelsArtificial IntelligenceClinical Decision supportDecision Support Systems, ClinicalMultidisciplinary tumour board (RCP)Patient Care TeamMedical oncologyNeoplasmsBenchmarkBenchmarkingConcordanceWeighted kappaSynthetic dataPatient safetyReproductibility

Outcome Measures

Primary Outcomes (1)

  • Domain-level performance between LLM recommendations and the locked guidelines.

    For each recommendation domain and each LLM, proportion of LLM recommendation concordant with locked guidelines

    Assessed once at central scoring, after data collection (~October 2026)

Secondary Outcomes (7)

  • Proportion of recommendations carrying serious harm potential ( LLM and tumour boards)

    Up to October 2026

  • Domain-level recommendation concordance between LLM and tumour-boards

    Up to October 2026

  • Inter-tumour board domain-level recommendation concordance

    Up to October 2026

  • Equipoise rate

    Up to October 2026

  • Completeness

    Up to October 2026

  • +2 more secondary outcomes

Study Arms (5)

Breast cancers

Other: Multidisciplinary tumour boardsOther: Frontier large language models

Lung cancers

Other: Multidisciplinary tumour boardsOther: Frontier large language models

Urological cancers

Other: Multidisciplinary tumour boardsOther: Frontier large language models

Digestive cancers

Other: Multidisciplinary tumour boardsOther: Frontier large language models

Gynaecological cancers

Other: Multidisciplinary tumour boardsOther: Frontier large language models

Interventions

Two independent tumour boards per localisation (10 boards in total) issue a categorical recommendation for every synthetic case. Where both boards agree, their consensus defines the reference standard; where they differ, the case-domain is classified as EQUIPOISE and analysed separately.

Breast cancersDigestive cancersGynaecological cancersLung cancersUrological cancers

Five frontier LLMs (GPT-5.6, Claude Fable 5, Gemini 3.1 Pro, DeepSeek V4 Pro, Llama 4 Maverick) each receive the identical structured input for every case, three times in independent sessions, under locked prompts, versions and settings.

Breast cancersDigestive cancersGynaecological cancersLung cancersUrological cancers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 synthetic oncology treatment-planning cases (20 per localisation) across five localisations: breast, lung, urological (prostate, bladder / upper-tract urothelial, kidney), digestive and gynaecological. Each case is a structured JSON input specifying UICC 8th-edition stage, biomarkers, ECOG performance status, comorbidities and a standardised clinical question. No human participants, no patient data and no identifiable individuals. Recommendations are produced by two independent tumour boards per localisation and by five frontier LLMs (queried May 2026).

You may qualify if:

  • Synthetic oncology case within one of the five predefined localisations (breast, lung, urological, digestive, gynaecological).
  • Complete structured schema: UICC 8th-edition stage, biomarkers, ECOG performance status, comorbidities and a standardised clinical question.
  • A clinically answerable treatment-planning question that is mappable to the locked guideline matrix.

You may not qualify if:

  • Case outside the five predefined localisations.
  • Incomplete, internally inconsistent or ambiguous schema.
  • Duplicate or near-duplicate of an existing case in the set.
  • Question not resolvable by current guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Européen Georges Pompidou

Paris, France

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsUrologic NeoplasmsProstatic NeoplasmsUrinary Bladder NeoplasmsKidney NeoplasmsDigestive System NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesUrinary Bladder DiseasesKidney DiseasesDigestive System Diseases

Central Study Contacts

Jean-Emmanuel Bibault, MD PhD

CONTACT

Jérôme Lambert, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations