Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015
GlioUnder5
1 other identifier
observational
50
1 country
1
Brief Summary
High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2018
CompletedFirst Submitted
Initial submission to the registry
June 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2019
CompletedApril 4, 2019
June 1, 2018
1 year
June 28, 2018
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assessment of patient survival associated with relapse rate after surgery
10 years
Assessment of patient survival associated with relapse rate after chemotherapy
10 years
Eligibility Criteria
Children under 5 years old with high grade glioma (WHO status III or IV)
You may qualify if:
- Children under 5 years old
- High grade glioma (WHO status III or IV)
- No previous treatment with chemotherapy or radiotherapy
- No contraindication to chemotherapy
- Consent of legal representative for participation in the study
You may not qualify if:
- Low grade glioma
- Any other histological pattern
- Parent's denial to access data concerning their child in the frame of medical research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Pédiatrie 3
Strasbourg, 67098, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Natacha ENTZ-WERLE, MD, PhD
University Hospital, Strasbourg, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2018
First Posted
October 1, 2018
Study Start
May 9, 2018
Primary Completion
May 9, 2019
Study Completion
May 9, 2019
Last Updated
April 4, 2019
Record last verified: 2018-06