Hope, a pioneering decentralized clinical study in breast cancer
Real-world genomic data for breast cancer treatment
Challenge
To use comprehensive genomic data on treatment decision-making for patients with advanced or metastatic breast cancer.
Solution
A low-code platform for multimodal data analysis and integration with a patient portal and app for trial recruitment and follow-up, streamlining research workflows.
Results
Hope has successfully recruited all 600 study participants in 16 months, 400 of them in just 6 weeks, a remarkable achievement. Half of the patients have already received a report evaluating their eligibility for a targeted therapy.
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.
“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”
Our solution is certified with ISO/IEC standards 27001, 27017 and 27018, ensuring compliance with applicable data protection laws and regulations including GDPR and HIPAA.
