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Given the highly encouraging results of the French SeDeN project regarding anticipated acceptability among professionals and parents, it is now appropriate to launch a similar pilot project in France, in collaboration with other international initiatives under the International Consortium on Newborn Sequencing framework.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>PERIGENOMED is a large-scale project designed to provide the first concrete evidence on the relevance of gNBS in France. It includes two clinical trials. We present here the design chosen for the first clinical trial (PERIGENOMED-CLINICS 1). PERIGENOMED-CLINICS 1 aims to assess the feasibility, real-world acceptability, psychosocial impact and organisational pathways of panel-based genomic newborn screening in France, involving 2500 participants. Solo-GS targeting two lists of gene\u2013disease dyads responsible for treatable (list 1; 400 genes, 171 diseases\/group of diseases) or actionable (list 2 optional; 407 genes, 218 diseases\/group of diseases) rare and severe early-onset diseases will be proposed in five health institutions. Ancillary social and impact studies will also be included.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>All study procedures have been reviewed and approved by relevant French ethics committees and regulatory authorities (CPP Est II-2024-A02224-43, 1 January 2025). Results of the project will be disseminated through peer-reviewed publications, national and international conferences, and public engagement initiatives, in coordination with stakeholders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06875089\">NCT06875089<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-105752","type":"journal-article","created":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T08:55:45Z","timestamp":1761209745000},"page":"e105752","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["PERIGENOMED-CLINICS 1\u2014the first study on feasibility, acceptability and psychosocial impact of PERIGENOMED: a pilot project aimed at providing initial concrete evidence on the relevance of panel-based genome sequencing for newborn screening (NBS) in France"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06875089","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06875089","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Camille","family":"Level","sequence":"first","affiliation":[{"name":"CHU Dijon-Bourgogne, INSERM, CTM UMR1231, \u00e9quipe GAD, FHU TRANSLAD, Centre de g\u00e9n\u00e9tique, 21000, Universit\u00e9 Bourgogne Europe, Dijon, Bourgogne-Franche-Comt\u00e9, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christel","family":"Thauvin-Robinet","sequence":"additional","affiliation":[{"name":"CHU Dijon Bourgogne, INSERM, CTM UMR1231, \u00e9quipe GAD, FHU TRANSLAD, Laboratoire de G\u00e9nomique M\u00e9dicale, 21000, Universit\u00e9 Bourgogne Europe, Dijon, Bourgogne-Franche-Comt\u00e9, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9417-5754","authenticated-orcid":false,"given":"Christine","family":"Binquet","sequence":"additional","affiliation":[{"name":"CHU de Dijon Bourgogne, INSERM, CTM UMR1231, FHU TRANSLAD, Centre d\u2019Investigation Clinique - Epid\u00e9miologie Clinique 1432, 21000, Universit\u00e9 Bourgogne Europe, Dijon, Bourgogne-Franche-Comt\u00e9, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yannis","family":"Duffourd","sequence":"additional","affiliation":[{"name":"CHU Dijon Bourgogne, INSERM, CTM UMR1231, \u00e9quipe GAD, FHU TRANSLAD, Laboratoire de G\u00e9nomique M\u00e9dicale, 21000, Universit\u00e9 Bourgogne Europe, Dijon, Bourgogne-Franche-Comt\u00e9, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emeline","family":"Davoine","sequence":"additional","affiliation":[{"name":"CHU 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