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Objectives

 

The TransBioBC project aims to translate the extensive foreground work undertaken within the contexts of the FP7 EU projects DECanBio and GENINCA by the TransBioBC Consortium Members. The strategic aim is to develop optimal non-invasive urine tests, based on biomarker (BM) classifiers, for monitoring Bladder Cancer (BC) recurrence and progression in routine clinical practice.

The specific project objectives include:

  • Optimization of technological platforms for assessing the identified biomarkers in routine clinical settings.
  • Development and validation of BM classifiers for the early detection of BC recurrence and/or progression.
  • Evaluation of the potential added value, including cost-effectiveness, of utilizing aforementioned BM classifiers in predicting BC recurrence and/or progression.
  • Exploitation of the derived BM classifier for clinical use in BC patient management, and as a "business-to-business" product in clinical trials conducted by either research institutions and/or the pharmaceutical industry.

 

 

Primary objective of our approach is to translate preliminarily verified BC.

 

Methodology

 

TransBioBC integrates leading BC related physicians (oncologists, urologists, and pathologists) with experts in clinical biomarker analysis in an implementation-oriented workflow (involving strict monitoring of assay analytical performance, properly collected and well characterized clinical samples, and multi-parametric statistical analysis) for elucidating the clinical validity and added value of new BM in the early detection of BC recurrence and/or tumor progression.

The study builds on the following two fundamental hypotheses: (1) the combination of BMs will render superior accuracy for detecting BC, and, (2) the selected markers have an increased potential for clinical applications based in some cases on strong existing evidence assessed by STARD and REMARK criteria.

The work is structured into 6 highly interrelated WPs targeting respectively:

  • WP1: Coordination of clinical studies and centres
  • WP2: BM measurements in urine
  • WP3: Statistical assessment of added value of the BMs and developing appropriate multi-marker classifiers
  • WP4: Industrial applications, including evaluation of cost effectiveness and marketing dissemination
  • WP5: Prototype Launch
  • WP6: Management of the consortium and dissemination activities

The workplan has been designed according to the general principles of regulatory agencies for biomarker validation, in an organized application –oriented format (Summarized in the Figure below)

Our approach involves two well defined clinical needs and contexts of use: 1) in patient surveillance for the early detection of BC recurrence, and 2) in patient prognosis assessment for BC recurrence and/or progression.

To achieve these aims, the project involves:

  1. Biomarkers that have undergone rigorous verification in independent test sets following their preliminary discovery (see Related Publications).
  2. Well-characterized platforms and analytical assays for the proposed BM: TransBioBC integrates the use of state-of-the-art technological platforms, as well as classical assays, for the measurements of the proposed BM.
  3. Adequate clinical resources to address the specific context of use and complementary partner expertise to successfully fulfill the required tasks.
  4. Efficient management plan for project implementation, as well as increased visibility and interactions with regulatory agencies.
  5. Evaluation of cost effectiveness and specific exploitation plans for the rapid dissemination of validated TransBioBC research findings.

A brief description of the main components of the workplan is provided in the Figure below.

Project evaluation and review technique (PERT) diagram. PERT method was applied to analyze the involved tasks in completing the project. Events are depicted as grey boxes and activities as arrows. For each activity time needed to complete the task and deliverable are given. The longest continuous pathway taken from the initial event to the terminal event defines the critical path and is highlighted in red. This path determines the total 36 months required for the project. Efficient project management will especially review the progress in this path, and ensure avoiding delays in reaching of the terminal event.