CARE PATHWAY “PILOT”

RESEARCH PROJECTS

The pilot projects aim to set up an operational and effective care pathway. They allow obstacles to be detected and concrete solutions to them to be found. Pilot projects including sequencing are carried out among cohorts of specific patients.

The implementation of high-throughput genome sequencing in our country means being faced with a number of technological, scientific, clinical and regulatory challenges. The purpose of the pilot projects is to test the care pathway deployed, including the implementation of high-throughput sequencing. The secondary objectives of these studies will provide general information:

  • Medico-economic in particular the financial and social impact for families. Social, with studies called SHS (Social and Human Science)

The important landmarks in the implementation of the pilot projects also involve the  genome sequencing platforms, CRefIX and the data collector analyser (DCA).

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The four “pilot” research projects address:

  • cancer (MULTIPLI – soft-tissue sarcoma),
  • rare diseases (DEFIDIAG – intellectual deficiency)
  • common diseases (GLUCOGEN – diabetes),
  • a general population study (POPGEN), intended to identify the genetic variants present in the French population. It will serve as an aid in the interpretation of the role of genetic variants identified in patients. POPGEN supports the Constances cohort and takes part in the Inserm genomic variability transversal programme GOLD.

The four pilot projects are operational. They associate specialist professionals of diverse backgrounds: clinicians, biologists, geneticians, bioinformaticians methodologists, health economists, personnel dedicated to research, etc.

All share the objective of making feasible high-throughput gene sequencing accessible to all, throughout the country.

WHERE ARE WE?

DEFIDIAG: obtained all regulatory approvals - November 2019

DEFIDIAG is a clinical trial in intellectual deficiency. The regulatory approvals of the French National Agency for Medicines and Health Products Safety (ANSM) and the French Data Protection Authority (CNIL) and the favourable opinion of the Institutional Review Board (CPP) have been obtained.

1st meeting around DEFIDIAG pilot project - November 2019

DEFIDIAG is a clinical trial in intellectual deficiency.

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DEFIDIAG is a clinical trial in intellectual deficiency.

MULTISARC (MULTIPLI): 1st patient enrolled - October 2019

MULTISARC is a clinical trial of the MULTIPLI pilot project in advanced soft-tissue sarcomas.

MULTIPLI: obtained all regulatory approvals - July 2019

MULTIPLI is a clinical trial in cancer. The regulatory approvals of the French National Agency for Medicines and Health Products Safety (ANSM) and the French Data Protection Authority (CNIL) and the favourable opinion of the Institutional Review Board (CPP) have been obtained.

POPGEN: validation of feasibility of saliva samples for genetic analysis. - June 2019

POPGEN is a clinical trial in the general population.
A scientific article is being published.

1st international scientific committee of DEFIDIAG pilot project - March 2018

DEFIDIAG is a clinical trial in intellectual deficiency.

MULTIPLI: validation of genetic circuit procedures - September 2017

MULTIPLI est un essai clinique sur le cancer. Un article scientifique est en cours de publication.

MULTIPLI: launch of a public-private partnership for the pilot project - March 2017

MULTIPLI is a cancer clinical trial.
The public-private partnership resulted from a selection of pharmaceutical companies.

1st Meeting of the International Scientific Committee of the MULTIPLI Pilot Project - January 2017

MULTIPLI est un essai clinique sur le cancer.

1st meeting on the DEFIDIAG pilot project - November 2016

DEFIDIAG is a clinical trial on intellectual disability.

1st meeting on the GLUCOGEN pilot project - September 2016

GLUCOGEN is the diabetes clinical trial.

1st meeting of the MULTIPLI pilot project - January 2016

MULTIPLI is a clinical trial in oncology.

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