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Spots Global Cancer Trial Database for Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia

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Trial Identification

Brief Title: Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia

Official Title: Non-interventional Study of Patients With Plexiform Neurofibromas and Neurofibromatosis Type I Starting Selumetinib in Russia

Study ID: NCT05891847

Conditions

Neurofibroma

Interventions

Study Description

Brief Summary: The purpose of this study is to evaluate the effectiveness, safety of selumetinib and patient's parameters of symptomatic inoperable PN NF1 in real clinical practice in Russia

Detailed Description: This study will be non-interventional retrospective and prospective study. Assessment of parameters will be carried out as if a patient is treated in real-life clinical setting. The patients should be enrolled into this project after evaluation of eligibility criteria by an investigator 10 clinical sites. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Study population will consist of pediatric patients aged 3 years and older with NF1 and symptomatic inoperable PN who were prescribed with selumetinib

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

GBUZ Morozovskaya Children City Clinical Hospital DZM, Moscow, Moskva, Russian Federation

GUZ MO Children Neuropsychiatric Hospital, Moscow, Moskva, Russian Federation

Scientific institute of pediatrics n.a. Veltishchev, Moscow, Moskva, Russian Federation

SMIC of children hematology, oncology and immunology n.a. D.Rogachev, Moscow, Moskva, Russian Federation

State Autonomous Healthcare Institution of the Sverdlovsk Region Regional Children Clinical Hospital, Ekaterinburg, , Russian Federation

Children Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan, Kazan, , Russian Federation

Novosibirsk State Medical University, Novosibirsk, , Russian Federation

Almazov National Medical Research Centre, Saint Petersburg, , Russian Federation

Raisa Gorbacheva Memorial Institute of Children Hematology and Transplantation, Saint Petersburg, , Russian Federation

St. Petersburg Clinical Scientific and Practical Center of Specialized Types of Medical Care, Saint Petersburg, , Russian Federation

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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