HOPE, a pioneering decentralized clinical study in breast cancer that exceeded participation expectations

HOPE by SOLTI is 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. It is highly relevant for its patient empowerment approach that has exceeded participation expectations.

HOPE, a pioneering decentralized clinical study in breast cancer that exceeded participation expectations

HOPE by SOLTI is 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. It is highly relevant for its patient empowerment approach that has exceeded participation expectations.

Challenge

Patient involvement in clinical trials is limited and sporadic at best. There is a need for more patient-centric approaches that ensure data collection and actively involve patients throughout the entire study.

Solution

A low-code platform for multimodal data storage and analysis that enables real-world data integration, together with a customized patient portal and a native App for clinical trial patient recruitment and follow-up.

Conclusion in numbers

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.

About solti

SOLTI is an academic research group that performs clinical trials of excellence in oncology. With a background of 77 clinical trials, they are positioned among the reference oncology groups at both national and international levels. Their mission is to promote innovative research that improves the well-being and prognosis of patients with breast cancer and other tumors. They strive to advance innovative research by supporting specialists in the development of translational clinical trials in oncology, especially in breast cancer. Their main activities involve academic, clinical and translational research, medical dissemination and scientific training programs with the aim of enhancing the talent of professionals and empower patients.

Logo SOLTI color

In 2020, SOLTI launches HOPE, a pioneering clinical study in Spain led by patients with metastatic breast cancer with Dra. Ana Casas and Dr. Aleix Prat as principal investigators of the study. HOPE’s main objective is to empower patients with metastatic breast cancer by collecting molecular tumor and real-life data through a mobile application (App).  This approach provides patients with unprecedented access to information about their condition, while also generating valuable data that can inform research and treatment approaches. By placing patients at the center of the study, HOPE seeks to revolutionize the way metastatic breast cancer is understood and treated, and offers hope to those affected by this challenging condition.

"This study arose as a result of an exchange of communication and reciprocal listening between patients and researchers to learn about the experiences and shortcomings of patients with metastatic breast cancer and to later be able to apply advanced diagnostic technology for cancer personalized treatment, according to the tumor biology of each patient”

CHALLENGE

Patient involvement in clinical trials regularly takes place in the last stages of the study and remains episodic. Barriers to participation range from lack of awareness, fear of experiments and time commitments. Moreover, there is a lack of standardization in data collection, especially for survey and real-world data (RWD), making it difficult to assess patient satisfaction and needs. Patients themselves have expressed their desire to be more involved and to perceive greater value from their participation in clinical trials. There is a need for a more patient-centric approach to clinical trial’s development, including standardized data collection methods that enhance data aggregation and reuse. 

HOPE aims to empower breast cancer patients by providing them with the information they need to make informed decisions about their care, in partnership with their reference oncologist. Patients have unprecedented access to insights about their condition, encouraging them to take an active role in their treatment. One of the key advantages of the study is the rapid patient registration process and data collection through the App, which allows researchers to focus all their efforts on data analysis and obtaining results. 

SOLUTION

A cutting-edge technology is required to obtain comprehensive information about patients’ disease and treatment history, as well as to analyze tumor and blood samples and obtain a molecular tumor profile that can guide treatment decision-making. Additionally, this technology should integrate information provided by the patient together with the genomic results, so that a committee of experts can collaboratively analyze the data and develop tailored clinical trial proposals or treatment recommendations.

For this project, Genomcore provided its GDPR and HIPAA-compliant platform for the store, management, standardization and integration of all datasets. This centralized data storage and analysis environment in the cloud is accessible from anywhere and can be adapted to the unique needs of each project so that participants can share data, metadata, analysis tools and results, facilitating seamless collaboration and unlocking the full potential of research data.

Genomcore’s Biomed platform provides 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. 

For the study SOLTI also used Genomcore Frontdesk, a unique, customizable self-service app and web portal, fully compliant with health and data protection laws, to help connect patients to healthcare providers. Genomcore Frontdesk is a content management system integrated in Genomcore Biomed that enables the delivery of clinical results, structured collection of health data, and enhances patient-provider relationships. Through the HOPE App, patients are proactively registered, healthcare professionals can easily retrieve patient’s health data through our questionnaire system and quality of life forms, centralizing the data collection process. In addition, patient’s follow-up is carried out throughout the study with push notifications ensuring direct interaction and communication with professionals, improving patient empowerment. Through the same App, the report is delivered in the desired format with the personalized recommendation carried out by the molecular advisory board once all the data has been integrated. The collective analysis of clinical and molecular data allows to expand knowledge and introduces new hypotheses that improve the approach to cancer. 

Thanks to this unique, anonymized patient database, which integrates real-world and genomic data, oncology experts and researchers will have an unprecedented opportunity to consider new hypotheses and continue investigating the complexities of this disease, accelerating the global knowledge of breast cancer. It represents indeed a significant step forward in the fight against breast cancer and a powerful tool for advancing the field of oncology.

For the study SOLTI also used Genomcore Frontdesk, a unique, customizable self-service app and web portal, fully compliant with health and data protection laws, to help connect patients to healthcare providers. Genomcore Frontdesk is a content management system integrated in Genomcore Biomed that enables the delivery of clinical results, structured collection of health data, and enhances patient-provider relationships. Through the HOPE App, patients are proactively registered, healthcare professionals can easily retrieve patient’s health data through our questionnaire system and quality of life forms, centralizing the data collection process. In addition, patient’s follow-up is carried out throughout the study with push notifications ensuring direct interaction and communication with professionals, improving patient empowerment. 

Through the same App, the report is delivered in the desired format with the personalized recommendation carried out by the molecular advisory board once all the data has been integrated. The collective analysis of clinical and molecular data allows to expand knowledge and introduces new hypotheses that improve the approach to cancer. Thanks to this unique, anonymized patient database, which integrates real-world and genomic data, oncology experts and researchers will have an unprecedented opportunity to consider new hypotheses and continue investigating the complexities of this disease, accelerating the global knowledge of breast cancer. It represents indeed a significant step forward in the fight against breast cancer and a powerful tool for advancing the field of oncology.

In this new challenge, SOLTI has 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) companies, which have provided its technologies for the molecular analysis. Genomcore has provided its low-code platform for multimodal data with a mobile solution (native App) and integrated patient web portal.

CONCLUSIONS IN NUMBERS

HOPE has managed to gather the 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 communities, 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”.”

At Genomcore we are very proud to contribute with our technological solutions to the SOLTI Hope project in the recruitment, interaction and collection of real-world data from patients, always with a focus on privacy and data security.