AI-generated Treatment Recommendations in Precision Oncology (AI-PRIME)

November 3, 2026 updated by: Damian Rieke, Charite University, Berlin, Germany

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.

Study Overview

Status

Recruiting

Conditions

Cancer

Intervention / Treatment

Other: large language model (non-interventional)

Study Type

Observational

Enrollment (Estimated)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Damian T Rieke, MD
Phone Number: +4930450 564 222
Email: cccc@charite.de

Study Locations

Germany
- - Berlin, Germany, 10117
    - Recruiting
    - Charité - Universitätsmedizin Berlin
    - Contact:
      
      Damian T Rieke, MD
      
      Phone Number: +49 30 450 564 222
      
      Email: damian.rieke@charite.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced solid tumors planning to undergo comprehensive molecular tumor testing

Description

Inclusion Criteria:

advanced solid tumor
>=18years
ECOG 0-1
comprehensive molecular tumor analysis planned

Exclusion Criteria:

lack of capacity to consent
hematological neoplasm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	immediately after the intervention (which is the molecular tumor board MTB; standard-of-care intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction of relevant treatment options among all retrieved treatment options (Precision) Time Frame: immediately after the intervention (MTB SOC intervention)	Positive predictive value as measured by retrieved relevant treatment options divided by all identified treatment options with 1 indicating the highest positive predictive value	immediately after the intervention (MTB SOC intervention)
Harmonic mean of precision and recall (F1-Score) Time Frame: immediately after the intervention (MTB SOC intervention)	Analysis of F1 score as harmonic mean between precision and recall with 0 indicating the lowest and 1 the highest possible score.	immediately after the intervention (MTB SOC intervention)
clinical trial identification Time Frame: immediately after the intervention (MTB SOC intervention)	Number of correctly identified clinical trials	immediately after the intervention (MTB SOC intervention)
time of manual and automatic annotation Time Frame: immediately after the intervention (MTB SOC intervention)	Comparison of time spent (in minutes) for manual and automatic molecular tumor result annotation	immediately after the intervention (MTB SOC intervention)
therapy implementation Time Frame: 3 months after MTB (SOC intervention)	Number of patients receiving recommended therapy and outcome	3 months after MTB (SOC intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

October 20, 2026

First Posted (Actual)

October 27, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

2026-109-CBF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.