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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03101813
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital Medical Center, Cincinnati
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lindsey Hoffman, DOTrent Hummel, MD
Principal Investigator Affiliation Phoenix Children's HospitalChildren's Hospital Medical Center, Cincinnati
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Courtney Blank

[email protected]

877-349-8074

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