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

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ClinicalTrials.gov Identifier: NCT03101813
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : September 10, 2022
The DIPG Collaborative
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease
Diffuse Intrinsic Pontine Glioma Diffuse Midline Glioma, H3 K27M-Mutant Diffuse Midline Glioma

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: International Diffuse Intrinsic Pontine Glioma (DIPG)/Diffuse Midline Glioma (DMG) Registry and Repository
Actual Study Start Date : June 2012
Estimated Primary Completion Date : June 2037
Estimated Study Completion Date : June 2047

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101813

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Contact: DIPG/DMG Operations Team 1-877-349-8074 referrals@dipgregistry.org

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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Courtney Blank    877-349-8074    referrals@dipgregistry.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
The DIPG Collaborative
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Study Chair: Lindsey Hoffman, DO Phoenix Children's Hospital
Principal Investigator: Trent Hummel, MD Children's Hospital Medical Center, Cincinnati
Additional Information:
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03101813    
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diffuse Intrinsic Pontine Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Stem Neoplasms
Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases