NCT03101813

Brief Summary

Doctors and other medical scientists want learn about the biology of DIPG/DMG and to develop better ways to diagnose and treat patients with DIPG/DMG. To do this, they need more information about the characteristics of DIPG/DMG tumors. Therefore, they want to establish a central location for clinical information and tumor tissue collected from DIPG/DMG patients. The purposes of this study are:

  • To enroll patients diagnosed with DIPG/DMG in the International DIPG/DMG Registry and Repository.
  • To provide a central location for clinical information, scans, and tissue samples from patients with DIPG/DMG enrolled in the registry.
  • To collect tissue samples in order to study how DIPG/DMG works on the molecular level. Researchers may use the tissue samples to study molecules such as proteins and DNA. Proteins are needed for the body to function properly and DNA is the molecule that carries our genetic information. Other researchers will be able to use the stored samples in the future to learn more about DIPG/DMG. The information researchers get from the research studies will be kept in the registry along with the clinical information.
  • To help investigators around the world to work together to make more consistent diagnosis and better design of future research studies. We hope this will lead to better treatments for DIPG/DMG in the future.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
256mo left

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jun 2012Jun 2047

Study Start

First participant enrolled

June 1, 2012

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
20.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2037

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2047

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

25 years

First QC Date

March 8, 2017

Last Update Submit

October 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identify the biological factors contributing to DIPG/DMG

    To implement a central repository for clinical, radiological, pathological and demographic data and specimens from patients with DIPG.

    Through study completion, anticipated to be 25 years

Secondary Outcomes (2)

  • Identify genetic and molecular signature of diffuse intrinsic pontine gliomas and diffuse midline gliomas.

    Through study completion, anticipated to be 25 years

  • Identify radiographic characteristics of DIPG/DMG

    Through study completion, anticipated to be 25 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients of any age (living or deceased) with a diagnosis (either current or past) of a DIPG/DMG tumor.

You may qualify if:

  • All patients of any age (living or deceased) with a diagnosis (either current or past) of a DIPG/DMG tumor
  • Unless the patient is deceased, all patients and/or one parent or legal guardian must provide written informed consent as well as HIPAA/release of information consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Sources of tumor tissue may be from diagnostic biopsy, surgery or autopsy samples. Fresh tumor tissue may be utilized immediately for biological studies.

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain Stem NeoplasmsInfratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Lindsey Hoffman, DO

    Phoenix Children's Hospital

    STUDY CHAIR
  • Trent Hummel, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DIPG/DMG Operations Team

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

April 5, 2017

Study Start

June 1, 2012

Primary Completion (Estimated)

June 1, 2037

Study Completion (Estimated)

June 1, 2047

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Clinical, radiographic, pathologic, genomic data and biological specimens may be released to qualified investigators after a subset of the study committee for this protocol has judged their proposals for scientific merit, clinical priority, and feasibility. Patient-identifying data/specimens will never be released to investigators. If the use of the samples and/or data released from the repository constitutes human subjects research per 45 CFR 46 or genetic research, IRB approval will be required to be submitted with the investigator's application.

Locations