Prospective Multicenter Study of Diffuse Intrinsic Pontine Glioma

JRCT ID: jRCT1030240186

Registered date:26/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: diffuse intrinsic pontine glioma (DIPG)
• Date of first enrollment: 12/06/2024
• Target sample size: 60
• Study type: Observational
• Intervention(s): none

Outcome(s)

• Primary Outcome: Overall Survival

Secondary Outcome

1) Progression-free survival (PFS)
2) Period during which Performance Status 70 or higher was maintained
3) Details and incidence of adverse events by treatment content
4) Changes in neurological findings over time
5) Response rate by treatment content
6) Annual number of registrants

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 30age old

Include criteria

Newly diagnosed DIPG patients
(Diagnosis based on guidelines for "Diffuse Intrinsic Pontine Glioma (DIPG)" issued by the Japanese Brain Tumor Society)
Tumors with the following characteristics on head MRI:
Located in the center of the pons, occupying more than 50% of the pontine cross-sectional area.
Indistinct borders.
Low signal intensity on T1.
High signal intensity on T2.
Gadolinium enhancement effect, if present, is irregular.
Without cystic formation or exposure to the surface of the pons (including the floor of the fourth ventricle).
(Source: https://www.jsn-o.com/guideline2021/dipg2021.html)
Age at diagnosis is under 30 years old.

Patients receiving or scheduled to receive treatment at medical institutions in Japan.

Prior to participating in this study, adequate explanation has been provided, and written consent has been obtained from the patient and/or surrogate (such as a guardian or legal representative capable of acting in the best interest of the research subject) as follows:

18 years and older: Written consent from the individual is sufficient if they have the capacity to understand (disclosure of diagnosis is mandatory).
16 to under 18 years old: Written consent is required from both the individual and the surrogate if the individual has the capacity to understand.
Under 16 years old: Written consent from the surrogate. In this case, use an assent document tailored to the patient's age to obtain their assent as much as possible.

• Exclude criteria: Patients deemed inappropriate by the principal investigator.

Related Information

• Primary Sponsor: Tomonari Suzuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development