Diffuse Intrinsic Pontine GliomaNCT03101813
International Diffuse Intrinsic Pontine Glioma (DIPG)/Diffuse Midline Glioma (DMG) Registry and Repository
An observational study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2047
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients of any age (living or deceased) with a diagnosis (either current or past) of a DIPG/DMG tumor.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Courtney Blank, 877-349-8074, referrals@dipgregistry.org
About this study
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.
Read the detailed description
There are limited data regarding the biology of diffuse intrinsic pontine gliomas (DIPG) and diffuse midline gliomas (DMG). This project provides the infrastructure for acquisition of biological specimens, imaging, and correlative clinical data to facilitate biology studies in this group of patients. The goal of the DIPG/DMG registry is to promote collaborations amongst investigators to allow timely data and/or specimen dissemination for future research studies and to develop classification systems, uniform standards of diagnosis, assessment and response, ultimately leading to the development of effective therapies for children with DIPG/DMG.
This registry will collect clinical, demographic, radiological and pathological data and specimens (if available) from patients with DIPG/DMG, both prospectively (in newly diagnosed or currently living patients), as well as retrospectively (in patients who are deceased). Cases are identified through:
- Existing clinical and/or cancer registry databases
- Referrals from clinicians, surgeons, or pathologists
- Families initiating contact with Registry staff directly
The following data/materials will be collected:
Clinical: Demographic data, date of diagnosis, signs and symptoms at diagnosis, laboratory data, detailed treatment data (e.g. types and dates of surgeries (if any), chemotherapy, radiotherapy), best response to treatment, dates of progression, types of progression (local or metastatic), and follow-up data.
Imaging: All radiographic imaging obtained since diagnosis will be requested at the time of study entry.
Pathology Central Review: If glass slides (stained or unstained) or paraffin blocks of tumor tissue (from biopsy or autopsy) are available, they will be requested at the time of registry entry but are not mandatory for enrollment.
Bioinformatics repository: Collection of existing molecular and/or genomic data or analysis that has been performed as well as prospective analysis of tissue from the registry will be submitted to a central bioinformatics repository and may be linked to clinical data housed in the DIPG/DMG registry.
Tissue Collection and Storage for Future Research: If available, participants' frozen tissue may be submitted for banking and future research.
Data stored in the Registry may be used to provide statistical data for scientific presentations and for preparation of peer-reviewed manuscripts. No personal data can be traced to the study manuscripts or presentations. Data and specimens will be released for research proposals upon approval from the International DIPG/DMG Registry Committee.
The International DIPG/DMG Registry and Repository is not associated with any oncology group cooperative study or treatment trial.
- Conditions
- Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
correlate registry data to a bioinformatics repository of molecular data on DIPG/DMG
Measured: Through study completion, anticipated to be 25 years
Identify radiographic characteristics of DIPG/DMG
develop classification systems, uniform standards of diagnosis, assessment and response
Measured: Through study completion, anticipated to be 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study startJun 2012
- Primary completionJun 2037 (estimated)
- Study completionJun 2047 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Intrinsic Pontine GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The DIPG Collaborative
- Responsible party
- Sponsor
- Investigators
- Lindsey Hoffman, DO, Study chair, Phoenix Children's HospitalTrent Hummel, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101813
- Sponsor's protocol ID
- DIPG/DMG-REGISTRY-REPOSITORY
- Status last verified
- Oct 2025
- First submitted
- 8 Mar 2017
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.