Recruiting

DIPG & DMG

Sponsor:

xCures

Code:

NCT06140719

Conditions

Oncology

DIPG

DMG

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Oncology

DIPG

DMG

Study ID

NCT06140719

Start date

Nov 1, 2023

Status verified date

Apr, 2024

Completion date

Jan, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

xCures Study Team

707-641-4475navigator@xcures.com

Locations

xCures, Inc.

Recruiting

Los Altos, California, United States, 94022

More Information

Sponsor

xCures

Last update posted

Apr 30, 2024

Last verified

Apr, 2024

Keywords

  • DIPG
  • DMG
  • Diffuse Midline Glioma
  • Diffuse Intrinsic Pontine Glioma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by xCures on 2024-04-30.