International Diffuse Intrinsic Pontine Glioma (DIPG)/Diffuse Midline Glioma (DMG) Registry and Repository

October 3, 2023 updated by: Children's Hospital Medical Center, Cincinnati

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.

Study Overview

Status

Recruiting

Conditions

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:

  1. Existing clinical and/or cancer registry databases
  2. Referrals from clinicians, surgeons, or pathologists
  3. 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.

Bioinfomatics 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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the biological factors contributing to DIPG/DMG
Time Frame: Through study completion, anticipated to be 25 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify genetic and molecular signature of diffuse intrinsic pontine gliomas and diffuse midline gliomas.
Time Frame: Through study completion, anticipated to be 25 years
correlate registry data to a bioinformatics repository of molecular data on DIPG/DMG
Through study completion, anticipated to be 25 years
Identify radiographic characteristics of DIPG/DMG
Time Frame: Through study completion, anticipated to be 25 years
develop classification systems, uniform standards of diagnosis, assessment and response
Through study completion, anticipated to be 25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

The DIPG Collaborative

Investigators

  • Study Chair: Lindsey Hoffman, DO, Phoenix Children's Hospital
  • Principal Investigator: Trent Hummel, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Estimated)

June 1, 2037

Study Completion (Estimated)

June 1, 2047

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIPG/DMG-REGISTRY-REPOSITORY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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