Use cases

Clinical Research

Hope, a pioneering decentralized clinical study in breast cancer

A leading real-world clinical practice study in Spain that assesses the impact of using comprehensive genomic data on treatment decision-making for patients with locally advanced or metastatic breast cancer.

Location

Spain

Size

600

About

Solti is a leading academic research group focused on oncology clinical trials. With 77 trials, they advance cancer research, particularly in breast cancer, to improve patient outcomes. They support specialists and conduct research, dissemination, and training to enhance professionals and empower patients. In this new challenge, Solti counted with the endorsement of the Spanish Association Against Cancer (AECC), the support of the Metastatic Breast Cancer (CMM), Attitude Against Cancer Foundation (AFC), and SARAY Associations, and the collaboration of Novartis Cancer Spain, Guardant Health and Roche Farma (Foundation Medicine solution).

features used in this project

  • Genomic Analysis

  • Compliance & Security

  • Unified Multimodal Datastore

  • Platform Engine

Project

How to leverage a platform to improve patient participation and data management

Fragmented clinical trial participation hinders progress. Hope empowered patients via data access and app-based engagement, promoting patient-centric research and accelerating results in breast cancer care.

Genomcore’s Biomed platform provided an intrinsic metadata system to ensure data is organized and structured effectively. This enables customized data models to be defined for each type of data, such as clinical and personal data, genomic data or the details of a laboratory experiment. The pseudo-anonymized data –being primary data and data resulting from the analyses– is stored in the platform and is made accessible only to partners via controlled user access.

Hope gathered 600 expected participants in just 16 months, compared to the initial forecast of 3 years. Currently, the genetic information of 326 of the 600 patients included in the trial has been analyzed, of which 177 have already received a report assessing their suitability of a targeted therapy. The HOPE study has included patients from all autonomous regions, being present in more than 47 Spanish provinces and in the autonomous city of Ceuta.

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"The large amount of data -always anonymous- that the project is allowing to collect, will be key to better understand the biology of this disease and carry out statistical analyses and draw conclusions from real-life data matching clinical and genomic data. We hope that all of this will serve to propose new solutions and research proposals for metastatic breast cancer”

Dr. Ana Casas, principal investigator of the study

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