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Histomolecular Profiles of Gliomas in Children and Adolescent/Young Adults (BioMol GLIOMA)

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ClinicalTrials.gov Identifier: NCT04916015
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

In the last decades, many advances have been made in the field of genetic abnormalities of glial and glioneuronal brain tumors. In the 2016 World Health organization (WHO) Classification of Tumors of the Central Nervous System, the concept of "integrated" diagnosis emerged: histological and genetic/molecular features now define many entities. Since 2016, six updates have been published by the c-IMPACT-NOW (the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy- Not Official WHO) to develop and clarify the "integrated" diagnosis. In the future WHO 2021 Classification of Tumors of the Central Nervous System, "integrated" diagnoses will take up even more importance. Even if they can have similar histological features, gliomas of children are very different from the "adult" gliomas in the molecular mechanism of oncogenesis. The histomolecular features of adolescents/young adults (AYAs) can have similarities with "pediatric-type" or "adult-type" gliomas, but few studies have focused specifically on the histomolecular profiles of gliomas in AYAs.

The investigators would like to study the cohort of patients treated for a glial and glioneuronal tumor diagnosed under the age of 25 in the Amiens University Hospital between 2008 and 2020. The investigators would like to compare the histomolecular profiles of gliomas in children (0-14 years) and AYAs (15-25 years).


Condition or disease
Histological Molecular Sequence Variation Glioma

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Comparative Study of the Histomolecular, Radiological and Prognostic Profiles Between Brain Gliomas of Children (0-14 Years) and Adolescents/Young Adults (15-25 Years) Treated in the Amiens University Hospital Between 2008 and 2020
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort
children (0-14 years)
AYAs (15-25 years)



Primary Outcome Measures :
  1. Histogical glioma differences between child group(0-14 years) and AYA group (15-25 years) [ Time Frame: one year ]
  2. Molecular glioma differences between child group(0-14 years) and AYA group (15-25 years) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Variation of glioma MRI profile between child group(0-14 years) and AYA group (15-25 years) [ Time Frame: one year ]
    MRI profiles are EPI T2* MRI profiles



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients treated for a glial and glioneuronal tumor diagnosed under the age of 25 in the Amiens University Hospital between 2008 and 2020.
Criteria

Inclusion Criteria:

  • Male or female patient
  • Patient treated in the Amiens University Hospital
  • Patient treated for a glial or glioneuronal brain tumor according to the 2016 WHO Classification of Tumors of the Central Nervous System ("diffuse oligodendroglia or astrocytoma tumour," "another astrocytic tumor," "another glioma" or a "mixed neuronal or glioneuronal tumour").
  • Diagnosis histologically confirmed or formally established by radiologist.
  • Diagnosis established between January 1, 2008 and December 31, 2020.
  • No patient opposition (from adult patient, or from the holder of parental authority of the minor patient).

Exclusion Criteria:

  • Uncertain diagnosis
  • Patient opposition (from adult patient, or from the holder of parental authority of the minor patient).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916015


Contacts
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Contact: Antoine Gourmel, MD 03.22.08.76.48. gourmel.antoine@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Antoine Gourmel, MD    03.22.08.76.48.    gourmel.antoine@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04916015    
Other Study ID Numbers: PI2021_843_0062
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Histological
Molecular
Glioma
adolescents/young adults
Children
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue