CLOSER is an international and complex project, divided into 9 work packages with the aim of distributing and organizing the different activities: research, innovation, patient engagement, ethics, coordination, communication, etc.

WP1 – Collaborative Coordination

Leader: Hospital Sant Joan de Déu de Barcelona

Aim: Ensure an excellent coordination and supervision of CLOSER, set-up an effective inter-partner communication.

Main tasks

1) Provide sustainable and efficient project coordination, while providing a fluent communication and interaction scheme between the partners

2) Ensure good and smooth cooperation with the European Commission

3) Ensure the on-time delivery of the deliverables, milestones, and reviews

4) Implement a call for expert, within the development of the project to ensure external expertise provided on a set of determined aspects of the translational research (i.e., ethics, patient involvement, business development, etc.)

5) Ensure a collaborative working scheme between the two continents

WP2 – Coordinated Identification and Delineation of Leukaemia Subtypes

Leader: St. Anna Children’s Cancer Research Institute (co-leader: Hospital de Pediatría Prof. Dr. Juan P. Garrahan)

Aim: Optimize and harmonize the genetic and immunophenotypic diagnosis of leukemia between Europe and Latin America. This harmonization will be tailored to the particularities of each partner regarding resources, logistics and other specific considerations.

Main tasks

1) Extract the current information on genetic sub-groups in childhood leukemia and compare their frequency between regions;

2) Assess the suitability of the current diagnostic methodologies to identify the leukemia subtypes and improve them to adapt to the shifting clinical demands;

3) Develop standardized operating procedures and establish quality assessment programs;

4) Define and explore rare, novel and unusual disease entities

WP3 – Optimization of the Measurable Residual Disease Assessment

Leader: Second Faculty of Medicine of the Charles University

Aim: Optimize and harmonize the follow up of the measurable residual disease (MRD) between Europe and Latin America.

Main tasks

1) Extract all the information about MRD technologies used for childhood leukemia monitoring in participating countries;

2) Assess the suitability of the used MRD techniques in the context of respective treatment protocols and situations, required technical equipment and skills of the staff. Offer solutions to improve the current practice for both flow and molecular MRD and education sessions and practical training by experienced centers;

3) Develop standardized operating procedures and quality assessment programs for both flow and molecular MRD. Provide feedback on the performance and troubleshooting for participants.

WP4 – Clinical Impact

Leader: Fundación Pérez Scremini (co-leader: Hospital Sant Joan de Déu de Barcelona)

Aim: Assess the prognostic impact of the leukemic subtypes identified along with other recognized prognostic factors in each country.

Main tasks

1) Analyze in each country the clinical impact of the main leukemic subtypes, incorporating other clinically validated prognostic variables and the MRD information when possible;

2) Assess in vitro the predictive sensitivity of the druggable lesions in high-risk patients.

WP5 – Training

Leader: Hospital Sant Joan de Déu de Barcelona (co-leader: Hospital de Niños Dr. Roberto del Río)

Aim: Enable access to training in the use of the different technologies needed for the current diagnosis of the different subtypes of childhood leukaemia and their follow-up. Create a stable network of training organized at various levels (local, national, international).

Main tasks

1) Define the requirements and personnel involved in the training;

2) Development of the training content and settings of the twinning program;

3) Ensure a training scheme with the interaction between trainees from participant institutions;

4) Consolidate the training and ensure accreditation processes;

WP6 – Childhood Leukaemia Patients’ Involvement

Leader: Fundación Natalí Dafne Flexer (co-leader: Asociación Pulseras Candela)

Aim: Ensure the cross-collaboration between the patient’s associations involved in CLOSER. Ensure the involvement of teenagers in the treatment and transition to adult hospitals issues. To empower patients and families by providing them with educational tools for disease management and quality of life.

Main tasks

1) Develop a cross-collaborative working plan between the different patients' associations involved;

2) Identification of the medical, logistical and other needs of the families of children with leukemia in the different countries of the consortium;

3) Identification of currently existent educational material on childhood leukemias; analysis of barriers and facilitators that will influence successful implementation of informative and awareness campaigns;

4) Creation of a special group dealing with the teenagers, and their own problematic, especially the transition path from children hospitals to adult hospitals;

5) Provide the parents, families, caregivers with a set of tools (i.e., crowdfunding) to set up or support existing patient associations.

WP7 – Cultural, Legal and Ethical Framework

Leader: Istituto Superiore di Sanità (co-leader: Fundación Natalí Dafne Flexer)

Aim: Formulate recommendations for ethical committee procedures in all the CLOSER involved countries. Deliver an ethical framework for the treatment and interventions within the perspective of the patient and caregivers. Ensure cultural adaptation training and framework for all the tasks and activities of the project.

Main tasks

1) Analyze the ethical committee procedures in preparation of the research across participant countries;

2) Develop a Country guide to explore the cultural and moral values and norms impacting the (attitude to the) expression and response to childhood leukemia and the compliance to treatment across participant countries;

3) Propose an ethical and cultural framework for the assessment of treatment of childhood leukemia and more generally speaking rare diseases, from the standpoint of the patients (children and teenagers), patient’s families and caregivers.

WP8 – Dissemination, Communication and Exploitation

Leader: Hospital Sant Joan de Déu de Barcelona (co-leaders: Hospital de Niños Dr. Roberto del Río y Fundación Pérez Scremini)

Aim: To effectively disseminate and communicate our results to directly benefit society, including project dissemination and communication strategy; to build on a sustainable knowledge transfer strategy.

Main tasks

1) Communicate and disseminate CLOSER’s message through conferences, open-access journals, website and social media, to reach out patients and families and the general public;

2) Contact scientific and general dissemination print and broadcast media of all European and Latin American countries involved;

3) Design a specific exploitation plan for each of the partners;

4) Use the social impact toolkit to ensure a sound and qualitative measurement;

5) Promote innovation: simplify the diagnostic approaches, by designing new affordable and effective diagnostic tools;

6) Develop and implement a specific innovation public tender with the support of local innovation organizations.

WP9 – Ethics

Leader: HSJD

Aim: The objective is to ensure compliance with the ethics requirements set out in this work package.