A Retrospective and Prospective Observational Sub-Study for Diffuse Midline Glioma and Diffuse Intrinsic Pontine Glioma
xCures
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.
Description
xPEDITE is a completely virtual, decentralized, nationwide,real-time, real-world observational study to collect, annotate, standardize, and report the critical data elements of DMG, inclusive of DIPG, in a regulatory-compliant framework. Patients participate by eConsent to the pan-cancer master observational protocol XCELSIOR (NCT03793088). This protocol is a sub-study of XCELSIOR and does not require an additional written consent. Medical records are accessed from institutions directly via eFax or paper fax, online from patient EMR portals, direct from DNA/RNA sequencing and molecular profili…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Patients with any performance status, comorbidity or disease severity are eligible 3. Patients or their legally-authorized representative must be willing and a…
Location
- xCures, Inc.Los Altos, California