NCT06140719 xPedite: A Study to Expedite DIPG and DMG Research
| NCT ID | NCT06140719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | xCures |
| Condition | Oncology |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-11-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Mark Shapiro, PhD
PRINCIPAL INVESTIGATOR
xCures
Frequently Asked Questions
Who can join the NCT06140719 clinical trial?
This trial is open to participants of all sexes, studying Oncology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06140719 currently recruiting?
Yes, NCT06140719 is actively recruiting participants. Contact the research team at navigator@xcures.com for enrollment information.
Where is the NCT06140719 trial being conducted?
This trial is being conducted at Los Altos, United States.
Who is sponsoring the NCT06140719 clinical trial?
NCT06140719 is sponsored by xCures. The principal investigator is Mark Shapiro, PhD at xCures. The trial plans to enroll 400 participants.