Clinical trial NCT05060835: ONCOlogy-targeted NLP-powered Federated Hyper-archItecture and Data Sharing Framework for Health Data Reusability
Official title: ONCOlogy-targeted NLP-powered Federated Hyper-archItecture and Data Sharing
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Prostate Cancer
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: University College Cork
name: Medical University of Gdansk
First posted: 2021-09-29
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of breast cancer and prostate cancer

Brief summary: ONCO-FIRE proposes to build a novel hyper-architecture and a common data model (CDM) for oncology, as well as a rich, modular toolset enabling significantly increased interoperability, exploitability, use and reuse of diverse, multi-modal health data available in electronic Health Records (EHR) and cancer big data repositories to the benefit of health professionals, healthcare providers and researchers; this will eventually lead to more efficient and cost-effective health care procedures and workflows that support improved care delivery to cancer patients encompassing support for cancer early prediction, diagnosis, and follow-up. The applicability, usefulness and usability of the proposed hyper-architecture, CDM and toolset for oncology and the high exploitability of health data will be demonstrated in diverse data exploitation scenarios related to breast and prostate cancer involving a number of Virtual Assistants (VAs) and advanced services offering to health care professionals (HCPs), hospital administration/healthcare providers and researchers data-driven decision-support and easy navigation across large amounts of cancer-related information. Through the above mentioned outcomes and the (meta)data interoperability achieved, ONCO-FIRE contributes to the exploitation of large volumes, highly heterogeneous (meta)data in EHR and data repositories including imaging data, structured data (e.g. demographics, laboratory, pathological data), as well as diverse formats of unstructured clinical reports and notes (e.g. text, pdf), including (but not limited to) temporal information related to the patient care pathway and genomics data currently "hidden" in unstructured medical reports, and more. Importantly, ONCO-FIRE interconnects, following a federated approach, large, distributed cancer imaging repositories, currently used for AI tools training and validation, with patient registries and EHRs of cancer-related data and supports exploitation of relevant unstructured data through novel Natural Language Processing (NLP) tools. The ultimate goal is to establish a patient-centric, federated multi-source and interoperable data-sharing ecosystem, where healthcare providers, clinical experts, citizens and researchers contribute, access and reuse multimodal health data, thereby making a significant contribution to the creation of the European Health Data Space.


Eligibility criteria: Inclusion Criteria:

* Patients of age ≥ 18 years.
* Individuals referred to hospitals for diagnosis and/or treatment of breast cancer or prostate cancer, either at first diagnoses, progression, or relapses.
* Availability of radiological images: 2D mammography or 2D synthetic digital tomosynthesis, ultrasound, and magnetic resonance for breast cancer; magnetic resonance for prostate cancer.
* Availability of pathological report (surgical specimen, including immunohistochemistry and genetic information).
* Availability of treatment allocation (neoadjuvant/Adjuvant and Advanced disease): (scheme, duration, benefit).
* Availability of treatment response evaluation

Exclusion Criteria:

* Patient with incomplete or low-quality data (radiological, pathological or clinical) In relation to the use of the data already existing in the four AI4HI repositories, ONCO-FIRE will not intervene with the inclusion and exclusion criteria of each of the four projects and will select those data that fit the ONCO-FIRE research purposes.

Primary outcomes:
measure: Estimation of Overall survival
timeFrame: Date of start of treatment untill Date of death or last contact/visit, assessed up to 2 years.
measure: Estimation of progression free survival
timeFrame: Date of start treatment until date of progression (measured by increase size in millimeters using radiological images), assessed up to 2 years.
Secondary outcomes:
measure: Estimation (%) of tumor aggressiveness non-respondents vs respondents to neoadjuvant treatment (breast):
timeFrame: Date of start of treatment until date of ending treatmen, responses will be assessed during the following 6 months after starting treatment in neoadyuvancy unless toxicity or progression has occurred
Other outcomes:
Locations:
Study officials:
References: