Clinical trials: sponsored by Centre Hospitalier Universitaire Dijon
Development Disorders
Secondary Findings From High-throughput Sequencing: How to Announce Them With Respect to the Patient's Needs
High-throughput whole-genome sequencing (WGS) is bringing new opportunities in the diagnosis of rare diseases. It will more frequently lead to a primary diagnosis (aim of the genetic consultation), but it may also lead to the…
- Trial name
- FIND (NCT03288727)
- Testing
- interviews with a psychologist
- Where
- 3 sites in France
- Volunteers
- 342 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Medical Termination of Pregnancy, Voluntary Termination of Pregnancy
Mechanisms and Factors Responsible for the Inhibition of Transposons During Fetal Gonad Development in Humans
This is a single-centre study over 36 months for the inclusion of 30 patients. The selection and inclusion of patients will take place according to the criterion of Medical Termination of Pregnancy at 4 different gestational ages…
- Trial name
- NCT02171845
- Testing
- surgical biopsies
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Genetic, Diagnostic Strategies
A Study of the Value of Trio Genome Sequencing in the Etiological Evaluation of Early-Onset and/or Atypical Psychiatric Disorders Without Intellectual Disability or Congenital Anomalies
According to the World Health Organization, one in eight people worldwide has a mental disorder, defined as a significant impairment in thinking, emotional regulation, or behavior.
- Trial name
- PSYGEN (NCT07686653)
- Testing
- Blood sample
- Where
- France
- Volunteers
- 255 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Intellectual Disability, Neurodevelopmental Disorder (Diagnosis)
Integration of New Generation Multi-omics Analyses for the Diagnosis of Genetic Neurodevelomental Disorders
Neurodevelopmental disorders (NDDs), including intellectual disability (ID), represent the most common indication for genetic testing.
- Conditions
- Intellectual Disability, Neurodevelopmental Disorder (Diagnosis), srGS, lrGS
- Trial name
- NEXTOMIX (NCT07755098)
- Testing
- Re-analysis of available srGS data, Re-analysis of available srGS data, followed by complementary analyses (lrGS sequencing, mRNA, and GMOs), srGS sequencing
- Where
- France
- Volunteers
- 132 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Developmental Abnormality
The Diagnostic Observatory: Combating Diagnostic Wandering and Impasse Within the AnDDI-Rares Network
The Direction Générale de l'Organisation des Soins (DGOS) and the Banque Nationale de Données Maladies Rares (BNDMR) have launched a call for a letter of commitment for the implementation of a diagnostic observatory in order to…
- Trial name
- Obs du Diag (NCT05448326)
- Testing
- Questionnaire to assess expectations of a diagnosis, Questionnaire to assess understanding of previously reported results and expectations of a diagnosis, Blood sample +/- skin biopsy
- Where
- France
- Volunteers
- 1,280 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Newborn Screening Programmes for Rare Diseases
A Pilot Study to Assess the Feasibility and Acceptability of Newborn Screening Using in Silico Panel-based Solo Genome Sequencing in France
Newborn Screening (NBS) based on genome sequencing (GS) is currently the subject of particular attention at both European and international levels.
- Trial name
- PGC1 (NCT06875089)
- Testing
- pGS-NBS, Satisfaction questionnaire, interview with HSS researcher
- Where
- 5 sites in France
- Volunteers
- 5,000 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Mother Who Has Given Birth to a Singleton Newborn, Mother-newborn Dyad
Olfactory Communication in the First Days of Life: From Chemical Mechanisms to Improved Breastfeeding
For a newborn, locating and latching onto the mother's breast is the foundational social interaction. This pivotal moment not only influences the newborn's survival but also determines the mother's physiological (lactation) and…
- Conditions
- Mother Who Has Given Birth to a Singleton Newborn, Mother-newborn Dyad, Singleton Newborn
- Trial name
- OD-ALL (NCT07616076)
- Testing
- Chemical description of the scent of the breast or a newborn, Breast secretion samples, The newborn and its role in colostrum secretion
- Where
- France
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Proven Pathogenic or Probably Pathogenic TBR1 Variant
A Study Evaluating 24 Months of Lithium Carbonate Treatment in Patients With TBR1-related Neurocognitive Disorder
TBR1 is a human gene encoding a brain-specific transcription factor, principally expressed in the excitatory neurons of the neocortex.
- Trial name
- ESALIT (NCT06776848)
- Testing
- Observation phase, Lithium treatment, biological monitoring
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Cerebral Palsy
Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performance of Children With Cerebral Palsy
Cerebral palsy is a common neurological disorder that is the leading cause of motor disability in children. It causes significant motor impairments, affecting various aspects such as fine and gross motor skills, as well as…
- Trial name
- Valid-ABLE (NCT07432789)
- Testing
- Assessment of functional abilities, Children's self-questionnaires, Parent self-assessment questionnaires
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Pathological Use of Internet Games
Efficacy of Transcranial Direct Current Stimulation (tDCS) in Patients Suffering From Pathological Use of Internet Gaming
The Internet has grown considerably in the last twenty years, and as a result, cases of excessive iinterney use have emerged. These cases, which have clinical similarities with substance addiction, involve the various activities…
- Trial name
- StimNET (NCT04120714)
- Testing
- Active tDCS, Questionnaires
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Cerebral Palsy
Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy
Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including…
- Trial name
- KAPP-IMU anc (NCT06138925)
- Testing
- Analysis of walking, Analysis of running
- Where
- France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Child Abuse
Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France
The epidemiological data currently available on child abuse in France are very inadequate. They do not make it possible to know the number of child victims, nor the precise context and impact of this violence.
- Trial name
- MENFIS (NCT04371484)
- Testing
- ICD-10
- Where
- France
- Volunteers
- 4,002,359 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Poikiloderma
Screening for Genes in Patients With Poikiloderma
In the context of this study, the investigators wish to take advantage of high-throughput genetic techniques (microarray and high-throughput exome sequencing) to identify new genes implicated in syndromic poikiloderma so as to…
- Trial name
- poikiloderma (NCT02862834)
- Testing
- High-throughput exome sequencing
- Where
- France
- Volunteers
- 39 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Inflammatory Bowel Diseases
Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases
: Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women.
- Trial name
- EVASION (NCT03134508)
- Testing
- treated by antiTNFα, not treated by antiTNFα
- Where
- France
- Volunteers
- 8,726 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Colorectal Cancer
Should Colorectal Cancer Patients be Followed After Five Years? Study of Recurrence in a Population Cohort
The results of this study will make it possible, thanks to better understanding of the natural history of colorectal cancer, to define new treatment and surveillance strategies for colorectal cancers resected with curative…
- Trial name
- NCT01904955
- Where
- France
- Volunteers
- 598 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Congenital Neutropenia
Screening for Genes in Patients With Congenital Neutropenia
Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases characterized by congenital neutropenia associated with the involvement of other organs.
- Trial name
- neutropenias (NCT02866162)
- Testing
- High-throughput exome sequencing
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Epileptic Encephalopathy of Unindentified Genetic Origin
Evaluation of the Diagnostic Contribution of High-throughput Exome Sequencing for Patients With Convulsive Encephalopathy of Unknown Etiology: Pilot Study to Improve Genetic Counselling
Congenital epileptic encephalopathies (EE) are predominantly genetic in origin. Their diagnosis is hampered by the large number of genes involved and their low recurrence.
- Trial name
- SHD-EE (NCT03652246)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)
Assessment of the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)
This study is a two periods multi-center Phase II trial, with a 6 months double-blind, placebo-controlled period followed by open label period, to assess the efficacy and safety of alpelisib (BYL719) in pediatric and adult…
- Trial name
- SESAM (NCT05577754)
- Testing
- Alpelisib (BYL719), Optional lumbar puncture + blood sample
- Where
- 13 sites in France
- Volunteers
- 20 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Drug-coated Balloon Catheter
Follow-up Study in French Practice to Evaluate Improvements in Walking and Pain Relief in Patients Treated With Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon
This study is part of the subordination for the renewal of the registration of the LUTONIXR035 or RANGERTM drug coated balloon catheter by the CNEDiMTS following the transmission of the results of a French study on quality of…
- Trial name
- EQUATEUR (NCT04798352)
- Testing
- 6-minute walk test, WIQ functional questionnaire, quality of life questionnaires (EQ5D5L and SF-36)
- Where
- France
- Volunteers
- 293 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Myocardial Infarction
Impact of Environmental Exposure at Home Address on One-year Post-myocardial Infarction Survival
Numerous studies have explored the effects of environmental exposure to noise, air pollution and proximity to "natural" areas on various conditions.
- Trial name
- ENVI-MI (NCT05449912)
- Testing
- Collection of environmental exposure data
- Where
- France
- Volunteers
- 982 people
- Sponsor
- Centre Hospitalier Universitaire Dijon