NCT05489783

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

August 1, 2022

Last Update Submit

June 25, 2026

Conditions

Keywords

NF1-associated gliomaNeurofibromatosisRegistry22-199

Outcome Measures

Primary Outcomes (1)

  • Registry of patients with Neurofibromatosis Type 1 (NF1) associated glioma

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering West Harrison (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, 11570, United States

RECRUITING

Related Links

MeSH Terms

Conditions

GliomaNeurofibromatoses

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeurofibromaNerve Sheath NeoplasmsNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Anna Piotrowski

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Piotrowski, MD

CONTACT

Ingo Mellinghoff, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 5, 2022

Study Start

July 29, 2022

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.

Locations