RECRUITING

xPedite: A Study to Expedite DIPG and DMG Research

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Retrospective and Prospective Observational Sub-Study for Diffuse Midline Glioma and Diffuse Intrinsic Pontine Glioma

Quick Facts

Study Start:2023-11-01
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06140719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Patients with any performance status, comorbidity or disease severity are eligible
  3. 3. Patients or their legally-authorized representative must be willing and able to provide electronic, informed consent (and assent, if applicable)
  4. 4. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088).
  5. 5. Patients must be a resident of or receiving care within the United States or US territories.
  1. 1. Patient or legally-authorized representative is unable to provide informed consent.
  2. 2. Patient or caregiver is unable to complete the PRO and ClinRO by an electronic platform.

Contacts and Locations

Study Contact

xCures Study Team
CONTACT
707-641-4475
navigator@xcures.com

Principal Investigator

Mark Shapiro, PhD
PRINCIPAL_INVESTIGATOR
xCures

Study Locations (Sites)

xCures, Inc.
Los Altos, California, 94022
United States

Collaborators and Investigators

Sponsor: xCures

  • Mark Shapiro, PhD, PRINCIPAL_INVESTIGATOR, xCures

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01
Study Completion Date2027-01

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Oncology
  • DIPG
  • DMG