NCT04916015

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

June 1, 2021

Last Update Submit

February 9, 2023

Conditions

Keywords

HistologicalMolecularGliomaadolescents/young adultsChildren

Outcome Measures

Primary Outcomes (2)

  • Histogical glioma differences between child group(0-14 years) and AYA group (15-25 years)

    one year

  • Molecular glioma differences between child group(0-14 years) and AYA group (15-25 years)

    one year

Secondary Outcomes (1)

  • Variation of glioma MRI profile between child group(0-14 years) and AYA group (15-25 years)

    one year

Study Arms (2)

children (0-14 years)

AYAs (15-25 years)

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 7, 2021

Study Start

June 1, 2021

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations