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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05489783
Other study ID # 22-199
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 29, 2022
Est. completion date July 29, 2025

Study information

Verified date October 2023
Source Memorial Sloan Kettering Cancer Center
Contact Anna Piotrowski, MD
Phone 212-610-0483
Email piotrowa@mskcc.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 29, 2025
Est. primary completion date July 29, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) Commack New York
United States Memorial Sloan Kettering West Harrison (All Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (All protocol activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (All Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (All Protocol Activities) Rockville Centre New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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