Clinical Validation of an AI-based approach to improve the shared decision-making process and outcomes in Breast Cancer Patients proposed for Locoregional treatment

Informations projet

CINDERELLA

N° de convention de subvention: 101057389

DOI

10.3030/101057389

Date de signature de la CE 23 Mai 2022

Date de début 1 Juin 2022

Date de fin 30 Novembre 2026

Financé au titre de

• Health

Coût total

€ 5 379 050,00

Contribution de l’UE

€ 5 378 299,00

Coordonné par

FUNDACAO D. ANNA DE SOMMER CHAMPALIMAUD E DR. CARLOS MONTEZ CHAMPALIMAUD
Portugal

Periodic Reporting for period 2 - CINDERELLA (Clinical Validation of an AI-based approach to improve the shared decision-making process and outcomes in Breast Cancer Patients proposed for Locoregional treatment)

Période du rapport: 2023-12-01 au 2025-05-31

Résumé du contexte et des objectifs généraux du projet

Breast cancer (BC) is the most commonly diagnosed cancer worldwide, with an estimated 2.3 million new cases each year. BC treatment usually combines surgery and radiotherapy (loco-regional treatment).

Breast surgery has evolved from radical mastectomy towards breast-conserving approaches and immediate reconstruction when mastectomy is needed. Radiotherapy techniques have also advanced, improving outcomes without compromising safety. However, when survival outcomes are similar, the choice between surgeries is strongly influenced by aesthetic concerns. Many patients struggle to anticipate how they will look after surgery, and about one-third report disappointment with the aesthetic result. Dissatisfaction may lead to psychological distress, negative self-image, and reduced quality of life (QoL).

The CINDERELLA Project proposes to integrate artificial intelligence (AI) to predict individual aesthetic outcomes and support evidence-based clinical decisions in BC treatment. Building on the BreLo-AI algorithm (previously developed to classify aesthetic results of BC loco-regional treatment) and a digital health platform designed specifically for BC, we developed the CINDERELLA APProach.

The CINDERELLA APP is a digital tool for women undergoing loco-regional BC treatment. It integrates AI-based image matching to predict likely outcomes, showing patients realistic visualisations based on photographs of women who underwent similar procedures. It also provides high-quality, multilingual educational resources, including videos for patients and caregivers. The aim is to improve shared decision-making, increase patient satisfaction, reduce psychological distress and revision surgeries, and ultimately enhance QoL.

The CINDERELLA Clinical Trial evaluates whether the APP improves patient expectations and QoL. Post-surgical data (clinical and photographic) are continuously fed into the AI platform, enabling learning and refinement.

The CINDERELLA APProach aims to reduce miscommunication between patients and clinicians, and could serve as a model for other treatments where aesthetics affect QoL.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

During the first 36 months, the main achievement was the full development of the CINDERELLA APP, enabling the launch of the clinical trial.

• The APP content was developed in six languages (English, German, Hebrew, Italian, Polish, Portuguese), with validated scientific accuracy. Patient information was structured into three levels of detail, allowing choice according to individual preference.

• Educational materials included state-of-the-art surgical and nursing videos, audio, and voice recordings in each language.

• Integration of BreLo-AI into the APP was successfully tested, allowing real-time use in the clinical trial.

• An AI torso morphing module was developed and validated in laboratory settings to further enhance patient visualisation. Although not yet integrated into the APP due to the trial timeline, it represents an important technical milestone with future potential.

• The trial recruited 1000 patients between August 2023 and May 2025. While recruitment is complete, the study will remain active until all patients complete their 12-month follow-up.

The APP runs on CANKADO, a certified digital health platform widely used across Germany, and beyond, for ePROs (electronic patient-reported outcomes), eConsent, and shared decision-making. This integration ensures compliance with data protection and regulatory standards and supports future scalability.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

As of month 36 (May 2025), no final scientific results are available yet, as the clinical trial has just completed recruitment and remains active until all patients finish the 12-month follow-up. While outcome data is expected after trial completion, the tools developed are fully functional and in use, representing a clear advancement beyond the current state of the art.

Key achievements include:

• The CINDERELLA Integrated Platform, combining BreLo-AI modules with the CANKADO platform.

• The BreLo-AI aesthetic scoring algorithm, case retrieval system, and torso morphing module.

• The BCCT.core extension for aesthetic evaluation.

• The CANKADO eConsent module, enabling digital and compliant patient enrolment.

• A large multicentre imaging and clinical dataset.

• A health technology assessment model to support cost-effectiveness and reimbursement discussions.

• Visual branding and a detailed clinical protocol for reuse in future projects.

The CINDERELLA Consortium has defined a clear go-to-market strategy combining public funding and private sector engagement. The primary path is submission to the European Innovation Council (EIC) Transition program, building on the project’s strong clinical, technical, and regulatory foundations. This funding would support product optimisation, targeted validation, and CE certification as a digital medical device, enabling faster European market entry while ensuring patient safety and compliance with MDR. In parallel, discussions with investors, philanthropic organisations, and industry partners are underway to secure complementary funding. This dual-track approach reflects growing market interest, safeguards clinical and commercial potential, and reduces risks in the transition from research to market, ensuring timely and scalable patient access.

Cinderella original picture