ClinicalTrials.gg
RecruitingNCT07897110AI-PRIMEUpdated Nov 5, 2026

AI-generated Treatment Recommendations in Precision Oncology

An observational study in Cancer, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Charite University, Berlin, Germany · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
191
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer

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Keywords

  • large language model
  • AI
  • molecular tumor board
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 191 is close to the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • lack of capacity to consent
  • hematological neoplasm
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
191 participants (estimated)
Patient registry
No

Interventions

  • Otherlarge language model (non-interventional)

    large language model (non-interventional)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: immediately after the intervention (which is the molecular tumor board MTB; standard-of-care intervention)

Secondary outcomes

  1. 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

    Time frame: immediately after the intervention (MTB SOC intervention)

  2. Harmonic mean of precision and recall (F1-Score)

    Analysis of F1 score as harmonic mean between precision and recall with 0 indicating the lowest and 1 the highest possible score.

    Time frame: immediately after the intervention (MTB SOC intervention)

  3. clinical trial identification

    Number of correctly identified clinical trials

    Time frame: immediately after the intervention (MTB SOC intervention)

  4. time of manual and automatic annotation

    Comparison of time spent (in minutes) for manual and automatic molecular tumor result annotation

    Time frame: immediately after the intervention (MTB SOC intervention)

  5. therapy implementation

    Number of patients receiving recommended therapy and outcome

    Time frame: 3 months after MTB (SOC intervention)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore F1-ScoreNow Harmonic mean of precision and recall (F1-Score)Time frame: immediately after the intervention (MTB SOC intervention)
Nov 5, 2026
Registered
First appeared on the registry
Oct 27, 2026
Show all 2 updates
  1. Nov 5, 2026
    Secondary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore F1-ScoreNow Harmonic mean of precision and recall (F1-Score)Time frame: immediately after the intervention (MTB SOC intervention)
    + 1 other change: verification date
  2. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07897110
Responsible party
Damian Rieke (PD Dr., Charite University, Berlin, Germany) — Principal investigator
First posted
Oct 27, 2026
Start date
Sep 1, 2026
Primary completion
Apr 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Damian T Rieke, MD
Contact
cccc@charite.de
+4930450 564 222

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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