← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2025-521385-10-00

ENDO-67 project: Investigating ENDOcrine therapy-related questions using Ki67 changes in the window-of-opportunity before breast surgery

Public registry stateAuthorised

CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation

REGISTRY FACTS

What CTIS publishes about this trial

EUCT number: 2025-521385-10-00
Trial status: Authorised
Sponsor: not published
Trial region: EEA
Phase: 6
Trial category: 3
Low-intervention trial: yes
Estimated EU start: 01 November 2025
Decision date: 21 October 2025
Published: 22 October 2025
Estimated end: 01 November 2030

EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“What is the concordance between Ki67 percentage measured by the pathologist versus an artificial intelligence (AI) algorithm”

Source field: authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[2].secondaryObjective
Matched term: artificial intelligence

MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

Breast cancer

Therapeutic areas

Diseases [C] - Neoplasms [C04]4

COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Netherlands

Authorised

First decision: 21 October 2025
Latest decision: 21 October 2025

21 October 2025Authorised
21 October 2025Authorised

TRIAL APPLICATIONS

Submission, decision and country state remain separate

INITIAL

Authorised

Trial status: Authorised
Submitted: 09 July 2025
Decided: 21 October 2025

Decisions21 October 2025 · Authorized

Country statusNetherlands · Authorised

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

09 July 2025Application Submitted
Application IN · Authorised
20 October 2025Country Assessment
Netherlands · Application IN · Authorized
21 October 2025Application Status
Application IN · Authorised
21 October 2025Country Decision
Netherlands · Application IN · Authorized
23 July 2026Trial Status Observed
Authorised

Observed by i6eal

First observed: 23 Jul 2026, 13:19
Last observed: 23 Jul 2026, 15:03
Materially modified: 23 July 2026

RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓

i6eal (2026): EU AI Studies Monitor, CTIS trial 2025-521385-10-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2025-521385-10-00/