RecruitingNCT06140719

xPedite: A Study to Expedite DIPG and DMG Research

A Retrospective and Prospective Observational Sub-Study for Diffuse Midline Glioma and Diffuse Intrinsic Pontine Glioma

Sponsor

xCures

Enrollment

400 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

Oncology DIPG DMG

Summary

This study will gather data from new and existing patients with patient medical records, and patient/family/caregiver reported information to establish a clear natural history of disease suitable to serve as an external, contemporary or historical control arm for future therapeutic development programs of drugs, devices, or biologic interventions in DMG or DIPG.

Eligibility

Inclusion Criteria5

Diagnosis of diffuse midline glioma according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
Patients with any performance status, comorbidity or disease severity are eligible
Patients or their legally-authorized representative must be willing and able to provide electronic, informed consent (and assent, if applicable)
Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088).
Patients must be a resident of or receiving care within the United States or US territories.

Exclusion Criteria2

Patient or legally-authorized representative is unable to provide informed consent.
Patient or caregiver is unable to complete the PRO and ClinRO by an electronic platform.