Glioma Developmental and HyperActive Ras Tumor (DHART) Board

October 5, 2023 updated by: Memorial Sloan Kettering Cancer Center

This study will collect medical records, scan results, and complete surveys to create a registry about people with a neurofibromatosis type 1-associated brain tumor (NF1-associated glioma). A registry is a collection of health information about individuals, and it is usually focused on a specific diagnosis or condition.

This registry study will help the researchers learn more about the diagnosis, treatment, and quality of life of people with NF1-associated glioma. The researchers want to understand what happens as a result of different treatments for NF1-associated glioma and how these treatments and the disease itself affect people's lives over a period of time. Information collected during this study could affect how doctors diagnose, test, and treat NF1-associated glioma, and the study could help future patients with this type of cancer.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

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 Contact Backup

  • Name: Ingo Mellinghoff, MD
  • Phone Number: 646-888-3036

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (All protocol activities)
        • Contact:
          • Anna Piotrowski, MD
          • Phone Number: 212-610-0483
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All protocol activities)
        • Contact:
          • Anna Piotrowski, MD
          • Phone Number: 212-610-0483
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Anna Piotrowski, MD
          • Phone Number: 212-610-0483
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
        • Contact:
          • Anna Piotrowski, MD
          • Phone Number: 212-610-0483
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering West Harrison (All Protocol Activities)
        • Contact:
          • Anna Piotrowski, MD
          • Phone Number: 212-610-0483
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Anna Piotrowski, MD
          • Phone Number: 212-610-0483
        • Contact:
          • Ingo Mellinghoff, MD
          • Phone Number: 646-888-3036
      • Rockville Centre, New York, United States, 11570
        • Recruiting
        • Memorial Sloan Kettering Nassau (All protocol activities)
        • Contact:
          • Anna Piotrowski, MD
          • Phone Number: 212-610-0483

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with NF1 glioma will be enrolled in this registry study.

Description

Inclusion Criteria:

  • Clinical diagnosis that meets NIH criteria for NF1 disease by either 1) documented clinical record establishing NF1 or 2) self-reported with supported documentation upon medical record collection.
  • Willing to have historical and future NF1 related health records sent to registry for review.
  • Radiologic or pathologically confirmed glioma.
  • Individuals ≥18 years of age on the date of informed consent.

Exclusion Criteria:

  • Unwillingness to sign informed consent.
  • No proficiency in English or Spanish as determined by the Investigator.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registry of patients with Neurofibromatosis Type 1 (NF1) associated glioma
Time Frame: 5 years
The overarching goal of the registry is to collect baseline and follow-up 1) clinical and 2) imaging data to have a centralized and living repository of information about the adult glioma NF1 patient population.
5 years

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Anna Piotrowski, Memorial Sloan Kettering Cancer Center

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)

July 29, 2022

Primary Completion (Estimated)

July 29, 2025

Study Completion (Estimated)

July 29, 2025

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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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