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International Diffuse Intrinsic Pontine Glioma (DIPG) Registry and Repository

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

Tracking Information
First Submitted Date March 8, 2017
First Posted Date April 5, 2017
Last Update Posted Date April 5, 2017
Actual Study Start Date June 2012
Estimated Primary Completion Date June 2037   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2017)
Identify the biological factors contributing to DIPG [ 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 30, 2017)
  • Identify genetic and molecular signature of diffuse intrinsic pontine gliomas. [ Time Frame: Through study completion, anticipated to be 25 years ]
    correlate registry data to a bioinformatics repository of molecular data on DIPG
  • Identify radiographic characteristics of DIPG [ Time Frame: Through study completion, anticipated to be 25 years ]
    develop classification systems, uniform standards of diagnosis, assessment and response
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Diffuse Intrinsic Pontine Glioma (DIPG) Registry and Repository
Official Title International Diffuse Intrinsic Pontine Glioma (DIPG) Registry and Repository
Brief Summary

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

The purposes of this study are:

  • To enroll patients diagnosed with DIPG in the International DIPG Registry and Repository.
  • To provide a central location for clinical information, scans, and tissue samples from patients with DIPG enrolled in the registry.
  • To collect tissue samples in order to study how DIPG 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. The information researchers get from the research studies will be kept in the registry along with the clinical information.
  • To help DIPG 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 in the future.
Detailed Description

There are limited data regarding the biology of diffuse intrinsic pontine gliomas (DIPG). 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 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.

This registry will collect clinical, demographic, radiological and pathological data and specimens (if available) from patients with DIPG, 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 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 Registry Committee.

The International DIPG Registry and Repository is not associated with any oncology group cooperative study or treatment trial.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Sources of tumor tissue may be from diagnostic biopsy, surgery or autopsy samples. Fresh tumor tissue may be utilized immediately for biological studies.
Sampling Method Probability Sample
Study Population All patients of any age (living or deceased) with a diagnosis (either current or past) of a DIPG tumor.
Condition Diffuse Intrinsic Pontine Glioma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 30, 2017)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2047
Estimated Primary Completion Date June 2037   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients of any age (living or deceased) with a diagnosis (either current or past) of a DIPG 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Brooklyn Chaney 1-877-349-8074 referrals@dipgregistry.org
Contact: Josh Baugh 1-877-349-8074 referrals@dipgregistry.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03101813
Other Study ID Numbers DIPG-REGISTRY-REPOSITORY
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description:

Clinical, radiographic, pathologic 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.

Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators The DIPG Collaborative
Investigators
Study Chair: Maryam Fouladi, MD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date March 2017