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Blood test for clinical therapy guidance of non-small cell lung cancer patients

Periodic Reporting for period 1 - LungCARD (Blood test for clinical therapy guidance of non-small cell lung cancer patients)

Reporting period: 2017-01-01 to 2018-12-31

The LungCARD project is dedicated to develop a blood test for clinical therapy guidance of non-small cell lung cancer (NSCLC) patients.

Lung cancer is the most common cancer worldwide. NSCLC alone make up about 75% of all lung cancers and most hospitals currently test all NSCLC patients for EGFR mutations (pharmacogenomics) for treatment decision (personalised medicine) – i.e. patients with mutation(s) in EGFR gene should receive a EGFR-Tyrosine Kinase Inhibitor (TKI) drug (e.g. afitinib) treatment; while those that do not present mutations in such gene, should be treated with chemotherapy.

Currently, the laboratories use PCR and Sanger sequencing technologies to perform the EGFR analysis from tumour biopsies - Fixed Paraffin Embedded (FFPE) samples. Still, some patients (e.g. 30% in UK) may never get histological confirmation because they are too sick to make a biopsy. Furthermore, the results obtained with current methods still present low quality, mainly due to poor quality/low yield of DNA extracted from FFPE samples.

The main project’s goal is to benefit citizens, through the development, improvement, integration and validation of the LungCARD system with NGS workflow and development of a software for automatic reporting clinical results.

LungCARD project aims to go further, by putting together a global and unique network of multidisciplinary scientists for exchange of knowledge and research training focused on non-small cell lung cancer.
WP1 (ORGANISATION AND MANAGEMENT): The LungCARD RISE project started with the Kick-off and General meetings. The main project´s rules, including a Consortium Agreement, were presented LungCARD Coordinator Dr. Orfeu Flores and Scientific Coordinator Dr. Carla Clemente and discussed among the members. The required material (e.g secondments plan, work to be carried out by each partner) was provided. The secondments organisation and work plan was discussed in one-to-one meeting (WP1).
A project logotype, Guide for Staff Exchange and website www.lungcardrise.eu as well as an internal platform containing project documentation was launched in March 2017.
The Mid Term Meeting occurred at Geneva on the 11th April, 2018 with the participation of the Consortium and European Commission.
On RISE 2018 Coordinators’ Day the LungCARD project manager Dr. Helena Gonçalves was invited to give testimonial about Ethics issues and how to handle them during a RISE project.

WP2 (CURRENT CLINICAL PRACTICES LANDSCAPE): Secondments were mainly focused in know-how exchange, available resources (e.g. equipments) and acquiring a global knowledge of current clinical practices related to Lung Cancer pharmacogenomics and therapy. The data associated with research and clinical practices in Lung cancer from 18 countries across 5 continents have been recorded. The data collection was reported in the deliverable D2.1 (Report on worldwide research and clinical practices related to Lung cancer pharmacogenomics and therapy) and a paper was published . Link: https://www.jbuon.com/pdfs/24-1/24-1-011-019.pdf

WP3 (FREEDOM-TO-OPERATE IN SEVERAL COUNTRIES): Information about legal regulations and practice regarding the NSCLC diagnostics and treatment, with the emphasis on targeted therapy in beneficiaries partners’ countries was collected (included in the report of protocol ID VI.1). Intelectual property rights (IPR) related to LungCARD system are planned to be assessed in next coming years at the country of each participant. In addition, the rights and obligations of project´s participants to access and protect the results generated in the project were described in the Consortium Agreement.

WP4 (RESEARCH FOR DEVELOPMENT OF LUNGCARD SYSTEM): The WP4 of LungCARD project aims to develop a LungCARD system used to generate the DNA target regions (biomarkers) associated with the selection of therapy in NSCLC from blood samples and automatic report of results (clinical report). A deliverable D4.2 was also reported that contains the description of reagents to be loaded in the LungCARD chip for circulating tumour cells enrichment and amplification of gene targeted regions associated with the selection of therapy in NSCLC.

WP5 (LUNGCARD SYSTEM VALIDATION): Planned to start after the finish of WP4 Spring 2019.

WP6 (LUNGCARD IMPLEMENTATION IN SEVERAL COUNTRIES): Planned to start at month 35

WP7 (COMMUNICATION, DISSEMINATION & KNOWLEDGE TRANSFER): The secondees are encouraged to attend/present workshops, seminars and conferences in the relevant topics for the project (e.g. micro fluidics chip, Next Generation sequencing, lung cancer disease, etc). EU funds were acknowledged in all the activities performed by LungCARD partners/beneficiaries.

WP8 (Ethics Requirements): Fully accomplished already. Also an independent Ethics Adviser was appointed to oversee the implementation of the ethical concerns involved in this research. The Report by Independent Ethics Advisor is attached to the Periodic Technical Report.
The LungCARD innovative solution is being developed to be positioned itself in the forefront of the market by enabling a more efficient pharmacogenomics that will allow for a more effective personalised medicine. Ultimately, this will allow to considerably decrease the overall ratio of mortality to incidence in Europe and worldwide, giving a new hope to lung cancer patients.

The progress beyond the state of the art is being put in place namely by testing other systems (eg: MinION).

LungCARD is working continuously to have the expected results until the end of the projects, although with some delays on WP 4. A considerable workload is being done to generate socio-economic impact and the wider societal implications. Please find bellow major actions that have been put in place:

1. Publication of a paper:

The LungCARD consortium created questionnaire to collect information about the local research and clinical practices related to lung cancer diagnosis and therapy in order to design and built a LungCARD system in accordance with legal, technical and research/clinical requirements.
A survey composed of 37 questions related to specific lung cancer pharmacogenomics and therapy, was distributed among 18 countries.
The data collection was reported in the deliverable D2.1 (Report on worldwide research and clinical practices related to Lung cancer pharmacogenomics and therapy) and a paper was published . Link: https://www.jbuon.com/pdfs/24-1/24-1-011-019.pdf

2. Master's thesis

The deliverable D4.3 is a Master thesis of a student from beneficiary “FCIENCIAS.ID “ which contains the description of the developed software to be used in the analysis of the NGS sequence data and automatic report of results.

3. Seminars | Info-days | Workshops

Seminars, Info-days and workshops have been an efficient way to engage selected audiences. LungCARD Consortium is been very active to inform the society about state-of-the-art in medical research in lung cancer and give them an overview of the LungCARD RISE project. Further details are included on D7_1Mid-term report on outreach activities.
STAB VIDA TEAM AT EUROPEAN UNION EMBASSY IN PERU WITH TEAM OF UNIV SAN MARTIN DE PORRES
Participants of the General Meeting , 9th March 2017 at STAB VIDA, auditorium of Faculdade Nova de L
STAB VIDA TEAM AT UNIVERSITY OF HULL