Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

NCT ID: NCT03690570

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-09

Study Completion Date

2019-05-09

Brief Summary

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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

Detailed Description

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Conditions

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Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Low grade glioma
* Any other histological pattern
* Parent's denial to access data concerning their child in the frame of medical research
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natacha ENTZ-WERLE, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Strasbourg, France

Locations

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Service de Pédiatrie 3

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Natacha ENTZ-WERLE, MD, PhD

Role: CONTACT

33.3.88.12.80.96

NIA GUENOVA, MD

Role: CONTACT

33.3.88.12.80.99

Facility Contacts

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Natacha ENTZ-WERLE, MD, PhD

Role: primary

33.3.88.12.80.96

Nia Guenova, MD

Role: backup

33.3.88.12.80.96

Other Identifiers

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6964

Identifier Type: -

Identifier Source: org_study_id

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