Clinical trial · Observational
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
NCT06140719CI-TRIAL-00076583recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DIPG | Diffuse Intrinsic Pontine Glioma | ALIAS | 0.90 |
| DMG | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- 12 months
- description
- OS is defined as time from first dose of treatment to death due to any cause.
Secondary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 12 months
- description
- ORR is defined as the proportion of patients with a documented complete response (CR) or partial response (PR) as assessed by RANO or RAPNO.
- measure
- Clinical Benefit Rate (CBR)
- timeFrame
- 12 months
- description
- CBR defined as the proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by RANO or RAPNO
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 able to provide electronic, informed consent (and assent, if applicable) 4. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088). 5. Patients must be a resident of or receiving care within the United States or US territories. Exclusion Criteria: 1. Patient or legally-authorized representative is unable to provide informed consent. 2. Patient or caregiver is unable to complete the PRO and ClinRO by an electronic platform.
References
Publications (0)
Data not yet available
No reference posted for this study.