DiagnosisALLIANCENCT07166692
Evaluation of a Retrieval Augmented Large Language Model as a Diagnostic Copilot in Rheumatology
A study testing Prof. Valmed in people with Diagnosis, run by Philipps University Marburg at 1 site in Germany.
Trial summary
This trial evaluates whether providing physicians with access to Prof. Valmed, a clinical decision support medical product, improves identification of rheumatic diseases and formulation of differential diagnoses compared with conventional decision support. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diagnosis
- What is being tested?
- Prof. Valmed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 12 Oct 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants must be licensed physicians.
- Training in rheumatology, internal medicine, emergency medicine, family medicine, dermatology or orthopedics.
Who cannot join
- Not currently practicing clinically.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Digital Medicine, University Hospital of Giessen and Marburg, Philipps University Marburg
Marburg, 35043
About this study
This trial evaluates whether providing physicians with access to Prof. Valmed, a clinical decision support medical product, improves identification of rheumatic diseases and formulation of differential diagnoses compared with conventional decision support.
Read the detailed description
Advanced AI, particularly large language models, shows promise for enhancing clinical reasoning, yet most systems such as ChatGPT are not certified as medical products. Prof. Valmed is a clinical decision support medical product designed to assist physicians in diagnostic decision making. Given frequent referral problems and diagnostic delays in rheumatology, evaluating such support is highly relevant for clinical workflows.
This randomized controlled trial will test whether access to Prof. Valmed improves physicians' diagnostic performance in cases of suspected rheumatic disease compared with conventional decision support. Participants will be randomized to either use Prof. Valmed or rely on conventional tools while working through standardized clinical cases. For each case, participants will submit up to three differential diagnoses and a confidence rating. Independent reviewers, blinded to group allocation, will adjudicate accuracy. Findings will clarify the benefits and limitations of integrating Prof. Valmed into routine practice.
- Conditions
- Diagnosis
- Being tested
- Prof. Valmed
- Keywords
- Clinical reasoning, Large language models, Computer-assissted diagnosis, Rheumatology
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prof. ValmedOther
Prof Valmed. decision support system.
| Study group | Role | What they receive |
|---|---|---|
| Prof. Valmed | Experimental | Group will be given access to Prof. Valmed. Receives: Other: Prof. Valmed |
| Control group | No intervention | Group will not be given access to Prof. Valmed but will be encouraged to use any resources they wish besides large language models (UpToDate, etc). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of top diagnosis
Participants in each group will make at least one disease suggestion (top diagnosis) and up to a total of a maximum of 3 suggestions. Percentage of exact matches of the top suggestion with the actual diagnosis will be analyzed
Measured: directly (within 10 minutes) after Intervention
Secondary outcomes (6)
Diagnostic accuracy of top 3 suggestions
Participants in each group will make at least one disease suggestion (top diagnosis) and up to a total of a maximum of 3 suggestions. Percentage of exact matches with the actual diagnosis included in the top 3 suggestions will be analyzed
Measured: directly (within 10 minutes) after Intervention
Diagnostic confidence
For each case participants will be asked for their diagnostic confidence (VAS 0-10). The mean score will be compared between groups.
Measured: directly (within 10 minutes) after Intervention
Time spent for diagnosis
We will compare how much time (in seconds) participants spend per case between the two study arms.
Measured: directly (within 10 minutes) after Intervention
Perceived Information Timeliness
Perceived ability to receive the information needed without delay (Likert scale from 1 to 5)
Measured: directly (within 10 minutes) after Intervention
Perceived diagnostic support quality
Perceived quality of the diagnostic support (Likert scale from 1 to 5)
Measured: directly (within 10 minutes) after Intervention
Diagnostic reasoning
For each case, participants will receive 1 point for each plausible diagnosis and 2 points for a completely correct response. The total scores will be compared between the randomized groups.
Measured: during evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start12 Oct 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Oslo University Hospital, Diakonhjemmet Hospital, University Hospital Erlangen, Charite University, Berlin, Germany, Rheumazentrum Ruhrgebiet, University of Lausanne Hospitals, Klinikum Fulda
- Responsible party
- Sponsor
- Investigators
- Johannes Knitza, MD PhD, Principal investigator, University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166692
- Sponsor's protocol ID
- 24-221-1
- Acronym
- ALLIANCE
- Status last verified
- Apr 2026
- First submitted
- 25 Aug 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Retrieval Augmented Large Language Model as a Diagnostic Copilot in Rheumatology
- ClinicalTrials.gov ID
- NCT07166692
- Acronym / sponsor ID
- ALLIANCE / 24-221-1
- Conditions
- Diagnosis
- Keywords
- Clinical reasoning, Large language models, Computer-assissted diagnosis, Rheumatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Oslo University Hospital, Diakonhjemmet Hospital, University Hospital Erlangen, Charite University, Berlin, Germany, Rheumazentrum Ruhrgebiet, University of Lausanne Hospitals, Klinikum Fulda
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial evaluates whether providing physicians with access to Prof. Valmed, a clinical decision support medical product, improves identification of rheumatic diseases and formulation of differential diagnoses compared with conventional decision support.
Detailed description
Advanced AI, particularly large language models, shows promise for enhancing clinical reasoning, yet most systems such as ChatGPT are not certified as medical products. Prof. Valmed is a clinical decision support medical product designed to assist physicians in diagnostic decision making. Given frequent referral problems and diagnostic delays in rheumatology, evaluating such support is highly relevant for clinical workflows.
This randomized controlled trial will test whether access to Prof. Valmed improves physicians' diagnostic performance in cases of suspected rheumatic disease compared with conventional decision support. Participants will be randomized to either use Prof. Valmed or rely on conventional tools while working through standardized clinical cases. For each case, participants will submit up to three differential diagnoses and a confidence rating. Independent reviewers, blinded to group allocation, will adjudicate accuracy. Findings will clarify the benefits and limitations of integrating Prof. Valmed into routine practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prof. Valmed | Experimental | Other: Prof. ValmedGroup will be given access to Prof. Valmed. |
| Control group | No intervention | –Group will not be given access to Prof. Valmed but will be encouraged to use any resources they wish besides large language models (UpToDate, etc). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must be licensed physicians.
- Training in rheumatology, internal medicine, emergency medicine, family medicine, dermatology or orthopedics.
Key exclusion criteria (1 listed)
- Not currently practicing clinically.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prof. ValmedProf Valmed. decision support system. | Other | Prof. Valmed |
Primary outcome
Diagnostic accuracy of top diagnosis
Time frame: directly (within 10 minutes) after Intervention
Participants in each group will make at least one disease suggestion (top diagnosis) and up to a total of a maximum of 3 suggestions. Percentage of exact matches of the top suggestion with the actual diagnosis will be analyzed
6 secondary outcomes
Diagnostic accuracy of top 3 suggestions
Time frame: directly (within 10 minutes) after Intervention
Diagnostic confidence
Time frame: directly (within 10 minutes) after Intervention
Time spent for diagnosis
Time frame: directly (within 10 minutes) after Intervention
Perceived Information Timeliness
Time frame: directly (within 10 minutes) after Intervention
Perceived diagnostic support quality
Time frame: directly (within 10 minutes) after Intervention
Diagnostic reasoning
Time frame: during evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Diagnosis
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
Systemic Sclerosis (SSc)
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingObservational study
A Longitudinal Study of Familial Hypereosinophilia (FE): Natural History and Markers of Disease Progression
Eosinophilia, Hypereosinophilic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Knitza, MD PhD principal investigator
University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prof. Valmed in people with Diagnosis, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of top diagnosis (time frame: directly (within 10 minutes) after Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.