CancerAI-PRIMENCT07897110
AI-generated Treatment Recommendations in Precision Oncology
An observational study of Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Non-interventional study to assess the non-inferiority of AI-generated treatment recommendations for precision oncology. Molecular tumor profiles will be assessed by local AI models to identify treatment options. Resulting treatment options will then be compared with actual personalized therapy recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- large language model (non-interventional)
- How many people
- 191 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced solid tumors planning to undergo comprehensive molecular tumor testing
Who may be able to join
- advanced solid tumor
- >=18years
- ECOG 0-1
- comprehensive molecular tumor analysis planned
Who cannot join
- lack of capacity to consent
- hematological neoplasm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Damian T Rieke, MD, +49 30 450 564 222, damian.rieke@charite.de
About this study
Official title: Eine Nichtunterlegenheitsstudie zu KI-generierten, Personalisierten Therapieempfehlungen für Die Präzisionsmedizin (AI-PRIME)
Non-interventional study to assess the non-inferiority of AI-generated treatment recommendations for precision oncology. Molecular tumor profiles will be assessed by local AI models to identify treatment options. Resulting treatment options will then be compared with actual personalized therapy recommendations.
- Conditions
- Cancer
- Being tested
- large language model (non-interventional)
- Keywords
- large language model, AI, molecular tumor board
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
large language model (non-interventional)Other
large language model (non-interventional)
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of all actual positively identified treatment options that the model has correctly identified (Recall)
Sensitivity as measured by retrieved relevant treatment options divided by all relevant treatment options with 1 indicating identification of all relevant treatment options.
Measured: immediately after the intervention (which is the molecular tumor board MTB; standard-of-care intervention)
Secondary outcomes (5)
Fraction of relevant treatment options among all retrieved treatment options (Precision)
Positive predictive value as measured by retrieved relevant treatment options divided by all identified treatment options with 1 indicating the highest positive predictive value
Measured: immediately after the intervention (MTB SOC intervention)
F1-Score
harmonic mean of precision and recall
Measured: immediately after the intervention (MTB SOC intervention)
clinical trial identification
Number of correctly identified clinical trials
Measured: immediately after the intervention (MTB SOC intervention)
time of manual and automatic annotation
Comparison of time spent (in minutes) for manual and automatic molecular tumor result annotation
Measured: immediately after the intervention (MTB SOC intervention)
therapy implementation
Number of patients receiving recommended therapy and outcome
Measured: 3 months after MTB (SOC intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Sep 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damian Rieke, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897110
- Sponsor's protocol ID
- 2026-109-CBF
- Acronym
- AI-PRIME
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eine Nichtunterlegenheitsstudie zu KI-generierten, Personalisierten Therapieempfehlungen für Die Präzisionsmedizin (AI-PRIME)
- ClinicalTrials.gov ID
- NCT07897110
- Acronym / sponsor ID
- AI-PRIME / 2026-109-CBF
- Conditions
- Cancer
- Keywords
- large language model, AI, molecular tumor board
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
Non-interventional study to assess the non-inferiority of AI-generated treatment recommendations for precision oncology. Molecular tumor profiles will be assessed by local AI models to identify treatment options. Resulting treatment options will then be compared with actual personalized therapy recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced solid tumors planning to undergo comprehensive molecular tumor testing
Key inclusion criteria (4 listed)
- advanced solid tumor
- >=18years
- ECOG 0-1
- comprehensive molecular tumor analysis planned
Key exclusion criteria (2 listed)
- lack of capacity to consent
- hematological neoplasm
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 |
|---|---|---|
| large language model (non-interventional)large language model (non-interventional) | Other | – |
Primary outcome
Fraction of all actual positively identified treatment options that the model has correctly identified (Recall)
Time frame: immediately after the intervention (which is the molecular tumor board MTB; standard-of-care intervention)
Sensitivity as measured by retrieved relevant treatment options divided by all relevant treatment options with 1 indicating identification of all relevant treatment options.
5 secondary outcomes
Fraction of relevant treatment options among all retrieved treatment options (Precision)
Time frame: immediately after the intervention (MTB SOC intervention)
F1-Score
Time frame: immediately after the intervention (MTB SOC intervention)
clinical trial identification
Time frame: immediately after the intervention (MTB SOC intervention)
time of manual and automatic annotation
Time frame: immediately after the intervention (MTB SOC intervention)
therapy implementation
Time frame: 3 months after MTB (SOC intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Charite University, Berlin, Germany 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damian T Rieke, MD (+4930450 564 222, cccc@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of all actual positively identified treatment options that the model has correctly identified (Recall) (time frame: immediately after the intervention (which is the molecular tumor board MTB; standard-of-care 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 27 Oct 2026.