- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05060835
ONCOlogy-targeted NLP-powered Federated Hyper-archItecture and Data Sharing Framework for Health Data Reusability (ONCO-FIRE)
25 oktober 2021 uppdaterad av: Instituto de Investigacion Sanitaria La Fe
ONCOlogy-targeted NLP-powered Federated Hyper-archItecture and Data Sharing
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Förväntat)
5000
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
patients of breast cancer and prostate cancer
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Breast Cancer
patients diagnosed with breast cancer at any stage.
|
the project will interconnect, 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
|
Prostate cancer
patients diagnosed with prostate cancer at any stage
|
the project will interconnect, 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Estimation of Overall survival
Tidsram: Date of start of treatment untill Date of death or last contact/visit, assessed up to 2 years.
|
The lenght (in days) of time form date of start of treatment for a disease that patients is still alive.
|
Date of start of treatment untill Date of death or last contact/visit, assessed up to 2 years.
|
Estimation of progression free survival
Tidsram: Date of start treatment until date of progression (measured by increase size in millimeters using radiological images), assessed up to 2 years.
|
The length of time (days) during and after treatment of a disease that a patient lives with the disease but it does not get worse.
|
Date of start treatment until date of progression (measured by increase size in millimeters using radiological images), assessed up to 2 years.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Estimation (%) of tumor aggressiveness non-respondents vs respondents to neoadjuvant treatment (breast):
Tidsram: 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
|
Proportion of patients who have complete response evaluating the target lesion according to Miller/Payne Grading system [Ogston et al., 2003]: 1A.
Evaluation of target Tumor: G5 as pathological complete response, no tumor left; G4: more than 90% loss of tumor cells; G3: between 30-90% reduction in tumor cells; G2: loss of tumor <30%; G1: no reduction.
1B: Evaluating the lymph nodes: A: negative; B: lymph nodes with metastasis and without changes by chemotherapy; C: lymph nodes with metastasis with evidence of partial response, D: lymph nodes with changes attributed to response without residual infiltration.
1C: Using images to evaluated radiological response: Size and diameter in millimeters of the target lesion using RM and TC or PET/CT for extension analysis (lymph nodes and metastasis).
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 juni 2023
Primärt slutförande (Förväntat)
1 juni 2025
Avslutad studie (Förväntat)
1 december 2025
Studieregistreringsdatum
Först inskickad
20 september 2021
Först inskickad som uppfyllde QC-kriterierna
20 september 2021
Första postat (Faktisk)
29 september 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 oktober 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 oktober 2021
Senast verifierad
1 september 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ONCO-FIRE
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
N/D
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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