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
1 other identifier
observational
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Typical duration 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
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 7, 2023
CompletedFirst Posted
Study publicly available on registry
November 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 30, 2024
April 1, 2024
2.8 years
November 7, 2023
April 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as time from first dose of treatment to death due to any cause.
12 months
Secondary Outcomes (2)
Objective Response Rate (ORR)
12 months
Clinical Benefit Rate (CBR)
12 months
Eligibility Criteria
Up to 400 patients of any age who have been diagnosed with diffuse midline glioma (DMG) or diffuse intrinsic pontine glioma (DIPG).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- xCureslead
Study Sites (1)
xCures, Inc.
Los Altos, California, 94022, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Shapiro, PhD
xCures
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2023
First Posted
November 20, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
April 30, 2024
Record last verified: 2024-04