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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-21

Study Completion Date

2026-03-20

Brief Summary

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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

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Detailed Description

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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

Conditions

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Neurofibroma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* NF1 diagnosed (according to the criteria for evaluating NF1),
* Symptomatic inoperable PN,
* Patients receiving therapy with selumetinib. For newly treated patients - registration on the first day of starting treatment with selumetinib,
* Age at starting of selumetinib treatment ≥ 3 to ≤ 18 years old (included in the study or started the therapy at the age of 18 years old),
* Patients whose parents or guardians have signed a consent form.

Exclusion Criteria

* Patients currently participating in an interventional study/clinical trial,
* Patients are excluded if there is evidence of an optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with chemotherapy or radiation therapy,
* Patients who receive other antitumor treatment options on optic nerve glioma, malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer. If the patient on selumetinib treatment develop optic nerve glioma, malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer, he can continue selumetinib therapy +\\- other treatment options on physician decision,
* Female patients above 12 age who are pregnant /plan to become pregnant or at breast feeding.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No