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ONCOlogy-targeted NLP-powered Federated Hyper-archItecture and Data Sharing Framework for Health Data Reusability (ONCO-FIRE)

2021年10月25日 更新者: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.

調査の概要

研究の種類

観察的

入学 (予想される)

5000

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

patients of breast cancer and prostate cancer

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Estimation of Overall survival
時間枠: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
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Estimation (%) of tumor aggressiveness non-respondents vs respondents to neoadjuvant treatment (breast):
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2023年6月1日

一次修了 (予想される)

2025年6月1日

研究の完了 (予想される)

2025年12月1日

試験登録日

最初に提出

2021年9月20日

QC基準を満たした最初の提出物

2021年9月20日

最初の投稿 (実際)

2021年9月29日

学習記録の更新

投稿された最後の更新 (実際)

2021年10月29日

QC基準を満たした最後の更新が送信されました

2021年10月25日

最終確認日

2021年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • ONCO-FIRE

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

N/D

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

乳がんの臨床試験

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3
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