A study to gather data on DIPG and DMG patients
A Retrospective and Prospective Observational Sub-Study for Diffuse Midline Glioma and Diffuse Intrinsic Pontine Glioma
This study is gathering information from patients with DIPG and DMG to help understand these conditions better and support future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | xCures Industry-sponsored |
| Locations | 1 site (Los Altos, California) |
| Trial ID | NCT06140719 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze data from patients diagnosed with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG). It utilizes a decentralized, virtual approach to gather medical records and patient-reported information, creating a comprehensive natural history of the disease. The data collected will serve as a control arm for future therapeutic development in DMG and DIPG. The study does not require additional consent beyond the existing XCELSIOR protocol and aims to standardize critical data elements for better understanding and treatment of these conditions.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with diffuse midline glioma or DIPG, regardless of their performance status or comorbidities.
Not a fit: Patients who are unable to provide informed consent or whose caregivers cannot participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that enhance the development of effective treatments for DIPG and DMG.
How similar studies have performed: While this approach is innovative, similar observational studies have shown promise in enhancing understanding of rare cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Altos, California
- xCures, Inc. — Los Altos, California, United States (Recruiting)
Study contacts
- Principal investigator: Mark Shapiro, PhD — xCures
- Study coordinator: xCures Study Team
- Email: navigator@xcures.com
- Phone: 707-641-4475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.